Back to resultsUpper Airway Reeducation in Moderate Obstructive Sleep Apnea Syndrome (SAOSGENIO)
Primary Purpose
Moderate Obstructive Sleep Apnea Syndrome
Status
Not yet recruiting
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Experimental
Sham comparator
Sponsored by
About this trial
This is an interventional treatment trial for Moderate Obstructive Sleep Apnea Syndrome
Eligibility Criteria
Inclusion Criteria: Male or female, 18 years old minimum Diagnosis of moderate OSAS: AHI ≥ 15 events/h and < 30 events/h at PSG M0 BMI < 35 kg/m2 Exclusion Criteria: MoCA < 26 (Montreal Cognitive Assessment) Craniofacial malformations Regular use of hypnotic medications Untreated hypothyroidism Stroke history Cardiac insufficiency Severe uncontrolled coronary heart disease Severe obstructive nasal disease Patients with indication for CPAP in first intention Pregnant or breastfeeding woman Current participation in another interventional research in OSA No affiliation to a social security system or legal beneficiary (except AME,Aide médicale d'état) Absence of free, informed, written consent Contraindications for TMS: intracranial metallic implant, pacemaker and/or recent or severe cardiac disease, epilepsy, vascular, traumatic, tumor, infectious or metabolic brain lesions, severe alcoholism Protected adult under guardianship or curatorship
Sites / Locations
- Service des pathologies du sommeil, Pitié-Salpêtrière hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Specific reeducation
Sham comparator
Arm Description
Specific reeducation
Sham reeducation
Outcomes
Primary Outcome Measures
Change in apnea-hypopnea index (AHI)
Apnea-hypopnea index (AHI) is the number of apnoeas or hypopnoeas per hour of sleep, measured by polysomnography during a minimum 6-hour night of inpatient sleep. Polysomnograms will be interpreted by a blinded somnologist.
Secondary Outcome Measures
Change of the Apnea-Hypopnea Index (AHI)
Apnea-hypopnea index (AHI) is the number of apnoeas or hypopnoeas per hour of sleep, measured by polysomnography during a minimum 6-hour night of inpatient sleep. Polysomnograms will be interpreted by a blinded somnologist.
Change of the MBLF(Bucco-Linguo-Facial Motor Function) score
Quantitative evaluation of the patient's lingual mobility by the speech therapist. The test consists of the execution of 13 lingual praxias rated from 0 (no contraction) to 3 (normal contraction), with a total score from 0 to 39
Change of the lingual strength
measured by collecting the maximum pressure in kPa with an tongueometer.
Change of lingual endurance
Following the same principle as lingual strength, lingual endurance (inversely proportional to fatigability) is measured with a tongueometer by quantifying the duration during which the patient can maintain 50% of his maximum pressure. The target value is then set to 50% of the patient's maximum pressure and the duration (in seconds)
Change of the size of the genioglossus representation in cm² within the motor cortex
by collecting motor evoked potentials of the genioglossus in response to transcranial magnetic stimulation (TMS) applied to the anterolateral region of the right vertex between 0 and 3 months.
Change of quality of life on the SF-36
Quality of life will be studied by the SF-36 generalist questionnaire completed by the patient. 36 items divided into 9 dimensions: physical activity, limitations due to physical condition, physical pain, perceived health, vitality, life and relationships with others, psychological health, limitations due to psychological condition, evolution of perceived health. Score from 0 (minimum subjective health) to 100 (maximum subjective health).
Change of sleep quality on the Pittsburgh Sleep Quality Index
Sleep quality will be studied by the Pittsburgh Sleep Quality Index completed by the patient.19 questions are divided into 7 composite scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, medication use, daytime dysfunctions) ranging from 0 (no difficulty) to 3 (severe difficulty). The global score is calculated by adding the 7 composite scores, the score obtained ranging from 0 to 21. The quality of sleep is investigated over the previous month.
Change of daytime drowsiness on the Epworth Drowsiness Scale
Daytime drowsiness will be studied by the Epworth Drowsiness Scale completed by the patient. 8 items rated from 0 (no chance of drowsiness) to 3 (systematic drowsiness), total score from 0 to 24. A score greater than or equal to 11 corresponds to daytime sleepiness.
Presence of subjective symptoms , each taken independently
subjective evaluation by the patient following questions:snoring every night or so (yes/no), high intensity of snoring (heard through a door or complaint from the entourage (yes/no),nocturia (yes/no) if yes frequency of episodes, morning headaches (yes/no),dry mouth at night or upon waking (yes/no),impression of non-restorative sleep (yes/no),bad sleep (yes/no), if yes, number of awakenings per nigh, fatigue (yes/no), daytime sleepiness (yes/no),impatience in the legs (yes/no),nightmares (yes/no), other symptoms (yes/no)
Change of the cervical circumference measurement (at the level of the cricoid)
in cm, using a tape measure
Change of the respiratory sensation sitting at rest
Using a visual analogue scale, consisting of a 10 cm plastic ruler graduated in mm presented horizontally. The side presented to the patient has a straight non graduated line, the left end of which corresponds to "no respiratory discomfort" and the right end to "intolerable respiratory discomfort".On the other side, there are millimetre graduations only visible to speech therapist. The position of the cursor chosen by the patient allows to read the intensity of the respiratory discomfort, which is measured in mm
Change of change in respiratory sensation between sitting and full decubitus
after the measurement of the respiratory sensation while sitting at rest, the patient is put in complete decubitus and the change of his respiratory discomfort between these 2 positions is measured. This change is collected using a visual analog scale, consisting of a 10 cm plastic ruler graduated in mm presented horizontally. The side presented to the patient has a straight, non-scaled line with "maximum aggravation" at the left end to "maximum improvement" at the right end, with a central marker to indicate "no change". On the other side, there are millimeter graduations only visible to speech therapist. The position of the cursor chosen by the patient allows to read the intensity of the respiratory discomfort, the results are expressed as a percentage of the full scale, the latter being defined as the distance between the central marker and one of the extremities, with a "+" sign for improvement and a "-" sign for worsening which is measured in mm.
Change of sleep latency
measured in minutes, during polysomnography in a minimum 6-hour night of inpatient sleep
Change of N3 latency
measured in minutes, during polysomnography in a minimum 6-hour night of inpatient sleep
Change of the paradoxical sleep latency
measured in minutes, during polysomnography in a minimum 6-hour night of inpatient sleep
change of sleep efficiency
calculated as total sleep time (TST) versus time from sleep to wakefulness (TWA), during polysomnography in a minimum 6-hour night of inpatient sleep
Change of the total sleep time (TST)
measured in minutes, during polysomnography in a minimum 6-hour night of inpatient sleep
Change of the length of the N1
measured in minutes, during polysomnography in a minimum 6-hour night of inpatient sleep
Change of the percentage (related to the TST) of the N1
measured in percentage of TST, during polysomnography in a minimum 6-hour night of inpatient sleep
Change of the length of the N2
measured in minutes, during polysomnography in a minimum 6-hour night of inpatient sleep
Change of the percentage (related to the TST) of the N2
measured in percentage of TST, during polysomnography in a minimum 6-hour night of inpatient sleep
Change of the length of the N3
measured in minutes, during polysomnography in a minimum 6-hour night of inpatient sleep
Change of the percentage (related to the TST) of the N3
measured in percentage of TST, during polysomnography in a minimum 6-hour night of inpatient sleep
Change of the length of paradoxical sleep
measured in minutes, during polysomnography in a minimum 6-hour night of inpatient sleep
Change of the percentage (related to the TST) of paradoxical sleep
measured in percentage of TST, during polysomnography in a minimum 6-hour night of inpatient sleep
Change of the length of intrasleep vigil
measured in minutes, during polysomnography in a minimum 6-hour night of inpatient sleep
Change of the percentage (related to the TST) of intrasleep vigil
measured in percentage of TST, during polysomnography in a minimum 6-hour night of inpatient sleep
Change of the index of micro-awakenings
Is the number of micro-awakenings per hour of sleep, measured by polysomnography during a minimum 6-hour night of inpatient sleep.
Change of the index of micro-awakenings of respiratory origin
Is the number of micro-awakenings of respiratory origin per hour of sleep, measured by polysomnography during a minimum 6-hour night of inpatient sleep.
Change of the number of periodic leg movements
Is the number of periodic leg movements per hour of sleep, measured by polysomnography during a minimum 6-hour night of inpatient sleep.
Change of number of sleep cycles
Is the number of sleep cycle, measured by polysomnography during a minimum 6-hour night of inpatient sleep.
Compliance with treatment
declared by the patient via the logbook given to the patient at the initial assessment. After each exercises session, the patient will have to complete the day, indicate the time spent and any difficulties encountered. Telephone follow-up of compliance will be carried out by the speech therapist or the clinical study technician every month. Compliance will be evaluated by the percentage of days when the patient will have declared to have carried out exercises for a duration higher than 50% of the theoretical duration of the exercises session
Full Information
NCT ID
NCT05911971
First Posted
June 12, 2023
Last Updated
June 12, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT05911971
Brief Title
Upper Airway Reeducation in Moderate Obstructive Sleep Apnea Syndrome
Acronym
SAOSGENIO
Official Title
Specific Upper Airway Reeducation in Moderate Obstructive Sleep Apnea Syndrome: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
April 2026 (Anticipated)
Study Completion Date
October 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to evaluate the effectiveness of a specific reeducation performed by speech therapists in moderate obstructive sleep apnea syndrome, as an alternative to the continuous Positive Anyway Pressure (CPAP) and the mandibular advancement device.
Detailed Description
Patients will be recruited in the sleep pathology department, following a sleep consultation and/or a polysomnography. They will be randomized between 2 reeducation groups (specific reeducation or sham reeducation) and will have to perform their respective exercises during 3 months. Only one of the 2 reeducations is expected to be effective. To limit performance and measure bias, patients will not be aware of the content of the reeducation in the other group (participants partially blinded of study hypothesis) and therefore these are not described in detail here. The initial clinical assessment will be repeated at 3 and 6 months, by assessors blinded to the reeducation arm, in order to evaluate the short and medium term effectiveness on the the Apnea-Hypopnea Index (AHI) and other outcomes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate Obstructive Sleep Apnea Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Specific reeducation
Arm Type
Experimental
Arm Description
Specific reeducation
Arm Title
Sham comparator
Arm Type
Sham Comparator
Arm Description
Sham reeducation
Intervention Type
Other
Intervention Name(s)
Experimental
Intervention Description
specific reeducation (not detailed to maintain blinding of participants)
Intervention Type
Other
Intervention Name(s)
Sham comparator
Intervention Description
sham reeducation (not detailed to maintain blinding of participants)
Primary Outcome Measure Information:
Title
Change in apnea-hypopnea index (AHI)
Description
Apnea-hypopnea index (AHI) is the number of apnoeas or hypopnoeas per hour of sleep, measured by polysomnography during a minimum 6-hour night of inpatient sleep. Polysomnograms will be interpreted by a blinded somnologist.
Time Frame
between 0 and 3 months after randomization
Secondary Outcome Measure Information:
Title
Change of the Apnea-Hypopnea Index (AHI)
Description
Apnea-hypopnea index (AHI) is the number of apnoeas or hypopnoeas per hour of sleep, measured by polysomnography during a minimum 6-hour night of inpatient sleep. Polysomnograms will be interpreted by a blinded somnologist.
Time Frame
between 0 and 6 months after randomization
Title
Change of the MBLF(Bucco-Linguo-Facial Motor Function) score
Description
Quantitative evaluation of the patient's lingual mobility by the speech therapist. The test consists of the execution of 13 lingual praxias rated from 0 (no contraction) to 3 (normal contraction), with a total score from 0 to 39
Time Frame
between 0 and 3 months and between 0 and 6 months after randomization
Title
Change of the lingual strength
Description
measured by collecting the maximum pressure in kPa with an tongueometer.
Time Frame
between 0 and 3 months and between 0 and 6 months after randomization
Title
Change of lingual endurance
Description
Following the same principle as lingual strength, lingual endurance (inversely proportional to fatigability) is measured with a tongueometer by quantifying the duration during which the patient can maintain 50% of his maximum pressure. The target value is then set to 50% of the patient's maximum pressure and the duration (in seconds)
Time Frame
between 0 and 3 months and between 0 and 6 months after randomization
Title
Change of the size of the genioglossus representation in cm² within the motor cortex
Description
by collecting motor evoked potentials of the genioglossus in response to transcranial magnetic stimulation (TMS) applied to the anterolateral region of the right vertex between 0 and 3 months.
Time Frame
between 0 and 3 months after randomization
Title
Change of quality of life on the SF-36
Description
Quality of life will be studied by the SF-36 generalist questionnaire completed by the patient. 36 items divided into 9 dimensions: physical activity, limitations due to physical condition, physical pain, perceived health, vitality, life and relationships with others, psychological health, limitations due to psychological condition, evolution of perceived health. Score from 0 (minimum subjective health) to 100 (maximum subjective health).
Time Frame
between 0 and 3 months and between 0 and 6 months after randomization
Title
Change of sleep quality on the Pittsburgh Sleep Quality Index
Description
Sleep quality will be studied by the Pittsburgh Sleep Quality Index completed by the patient.19 questions are divided into 7 composite scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, medication use, daytime dysfunctions) ranging from 0 (no difficulty) to 3 (severe difficulty). The global score is calculated by adding the 7 composite scores, the score obtained ranging from 0 to 21. The quality of sleep is investigated over the previous month.
Time Frame
between 0 and 3 months and between 0 and 6 months after randomization
Title
Change of daytime drowsiness on the Epworth Drowsiness Scale
Description
Daytime drowsiness will be studied by the Epworth Drowsiness Scale completed by the patient. 8 items rated from 0 (no chance of drowsiness) to 3 (systematic drowsiness), total score from 0 to 24. A score greater than or equal to 11 corresponds to daytime sleepiness.
Time Frame
between 0 and 3 months and between 0 and 6 months after randomization
Title
Presence of subjective symptoms , each taken independently
Description
subjective evaluation by the patient following questions:snoring every night or so (yes/no), high intensity of snoring (heard through a door or complaint from the entourage (yes/no),nocturia (yes/no) if yes frequency of episodes, morning headaches (yes/no),dry mouth at night or upon waking (yes/no),impression of non-restorative sleep (yes/no),bad sleep (yes/no), if yes, number of awakenings per nigh, fatigue (yes/no), daytime sleepiness (yes/no),impatience in the legs (yes/no),nightmares (yes/no), other symptoms (yes/no)
Time Frame
At 3 months and 6 months after randomization
Title
Change of the cervical circumference measurement (at the level of the cricoid)
Description
in cm, using a tape measure
Time Frame
between 0 and 3 months and between 0 and 6 months after randomization
Title
Change of the respiratory sensation sitting at rest
Description
Using a visual analogue scale, consisting of a 10 cm plastic ruler graduated in mm presented horizontally. The side presented to the patient has a straight non graduated line, the left end of which corresponds to "no respiratory discomfort" and the right end to "intolerable respiratory discomfort".On the other side, there are millimetre graduations only visible to speech therapist. The position of the cursor chosen by the patient allows to read the intensity of the respiratory discomfort, which is measured in mm
Time Frame
between 0 and 3 months and between 0 and 6 months after randomization
Title
Change of change in respiratory sensation between sitting and full decubitus
Description
after the measurement of the respiratory sensation while sitting at rest, the patient is put in complete decubitus and the change of his respiratory discomfort between these 2 positions is measured. This change is collected using a visual analog scale, consisting of a 10 cm plastic ruler graduated in mm presented horizontally. The side presented to the patient has a straight, non-scaled line with "maximum aggravation" at the left end to "maximum improvement" at the right end, with a central marker to indicate "no change". On the other side, there are millimeter graduations only visible to speech therapist. The position of the cursor chosen by the patient allows to read the intensity of the respiratory discomfort, the results are expressed as a percentage of the full scale, the latter being defined as the distance between the central marker and one of the extremities, with a "+" sign for improvement and a "-" sign for worsening which is measured in mm.
Time Frame
between 0 and 3 months and between 0 and 6 months after randomization
Title
Change of sleep latency
Description
measured in minutes, during polysomnography in a minimum 6-hour night of inpatient sleep
Time Frame
between 0 and 3 months and between 0 and 6 months after randomization
Title
Change of N3 latency
Description
measured in minutes, during polysomnography in a minimum 6-hour night of inpatient sleep
Time Frame
between 0 and 3 months and between 0 and 6 months after randomization
Title
Change of the paradoxical sleep latency
Description
measured in minutes, during polysomnography in a minimum 6-hour night of inpatient sleep
Time Frame
between 0 and 3 months and between 0 and 6 months after randomization
Title
change of sleep efficiency
Description
calculated as total sleep time (TST) versus time from sleep to wakefulness (TWA), during polysomnography in a minimum 6-hour night of inpatient sleep
Time Frame
between 0 and 3 months and between 0 and 6 months after randomization
Title
Change of the total sleep time (TST)
Description
measured in minutes, during polysomnography in a minimum 6-hour night of inpatient sleep
Time Frame
between 0 and 3 months and between 0 and 6 months after randomization
Title
Change of the length of the N1
Description
measured in minutes, during polysomnography in a minimum 6-hour night of inpatient sleep
Time Frame
between 0 and 3 months and between 0 and 6 months after randomization
Title
Change of the percentage (related to the TST) of the N1
Description
measured in percentage of TST, during polysomnography in a minimum 6-hour night of inpatient sleep
Time Frame
between 0 and 3 months and between 0 and 6 months after randomization
Title
Change of the length of the N2
Description
measured in minutes, during polysomnography in a minimum 6-hour night of inpatient sleep
Time Frame
between 0 and 3 months and between 0 and 6 months after randomization
Title
Change of the percentage (related to the TST) of the N2
Description
measured in percentage of TST, during polysomnography in a minimum 6-hour night of inpatient sleep
Time Frame
between 0 and 3 months and between 0 and 6 months after randomization
Title
Change of the length of the N3
Description
measured in minutes, during polysomnography in a minimum 6-hour night of inpatient sleep
Time Frame
between 0 and 3 months and between 0 and 6 months after randomization
Title
Change of the percentage (related to the TST) of the N3
Description
measured in percentage of TST, during polysomnography in a minimum 6-hour night of inpatient sleep
Time Frame
between 0 and 3 months and between 0 and 6 months after randomization
Title
Change of the length of paradoxical sleep
Description
measured in minutes, during polysomnography in a minimum 6-hour night of inpatient sleep
Time Frame
between 0 and 3 months and between 0 and 6 months after randomization
Title
Change of the percentage (related to the TST) of paradoxical sleep
Description
measured in percentage of TST, during polysomnography in a minimum 6-hour night of inpatient sleep
Time Frame
between 0 and 3 months and between 0 and 6 months after randomization
Title
Change of the length of intrasleep vigil
Description
measured in minutes, during polysomnography in a minimum 6-hour night of inpatient sleep
Time Frame
between 0 and 3 months and between 0 and 6 months after randomization
Title
Change of the percentage (related to the TST) of intrasleep vigil
Description
measured in percentage of TST, during polysomnography in a minimum 6-hour night of inpatient sleep
Time Frame
between 0 and 3 months and between 0 and 6 months after randomization
Title
Change of the index of micro-awakenings
Description
Is the number of micro-awakenings per hour of sleep, measured by polysomnography during a minimum 6-hour night of inpatient sleep.
Time Frame
between 0 and 3 months and between 0 and 6 months after randomization
Title
Change of the index of micro-awakenings of respiratory origin
Description
Is the number of micro-awakenings of respiratory origin per hour of sleep, measured by polysomnography during a minimum 6-hour night of inpatient sleep.
Time Frame
between 0 and 3 months and between 0 and 6 months after randomization
Title
Change of the number of periodic leg movements
Description
Is the number of periodic leg movements per hour of sleep, measured by polysomnography during a minimum 6-hour night of inpatient sleep.
Time Frame
between 0 and 3 months and between 0 and 6 months after randomization
Title
Change of number of sleep cycles
Description
Is the number of sleep cycle, measured by polysomnography during a minimum 6-hour night of inpatient sleep.
Time Frame
between 0 and 3 months and between 0 and 6 months after randomization
Title
Compliance with treatment
Description
declared by the patient via the logbook given to the patient at the initial assessment. After each exercises session, the patient will have to complete the day, indicate the time spent and any difficulties encountered. Telephone follow-up of compliance will be carried out by the speech therapist or the clinical study technician every month. Compliance will be evaluated by the percentage of days when the patient will have declared to have carried out exercises for a duration higher than 50% of the theoretical duration of the exercises session
Time Frame
at 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female, 18 years old minimum
Diagnosis of moderate OSAS: AHI ≥ 15 events/h and < 30 events/h at PSG M0
BMI < 35 kg/m2
Exclusion Criteria:
MoCA < 26 (Montreal Cognitive Assessment)
Craniofacial malformations
Regular use of hypnotic medications
Untreated hypothyroidism
Stroke history
Cardiac insufficiency
Severe uncontrolled coronary heart disease
Severe obstructive nasal disease
Patients with indication for CPAP in first intention
Pregnant or breastfeeding woman
Current participation in another interventional research in OSA
No affiliation to a social security system or legal beneficiary (except AME,Aide médicale d'état)
Absence of free, informed, written consent
Contraindications for TMS: intracranial metallic implant, pacemaker and/or recent or severe cardiac disease, epilepsy, vascular, traumatic, tumor, infectious or metabolic brain lesions, severe alcoholism
Protected adult under guardianship or curatorship
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diane PICARD-DUBOIS
Phone
0142163157
Email
diane.picard@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diane PICARD-DUBOIS
Organizational Affiliation
APHP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service des pathologies du sommeil, Pitié-Salpêtrière hospital
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diane PICARD-DUBOIS
Phone
0142163157
Email
diane.picard@aphp.fr
First Name & Middle Initial & Last Name & Degree
Diane PICARD-DUBOIS
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data are available upon reasonable request The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.
Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations
IPD Sharing Time Frame
Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
IPD Sharing Access Criteria
Researchers who provide a methodologically sound proposal.
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Upper Airway Reeducation in Moderate Obstructive Sleep Apnea Syndrome
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