Back to resultsPErsonalized and Adaptive Kinesthetic stImulation Therapy, Based on Cardio-respiratory Holter moNitoring, for Sleep Apnea syndrOmes (EKINOx)
Primary Purpose
Obstructive Sleep Apnea Syndrome
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Kinesthetic stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea Syndrome
Eligibility Criteria
Inclusion Criteria:
Patients who meet all the following criteria at the time of enrollment may be included:
- Man or woman aged more than 18 years old.
- Patient with severe obstructive apnea syndrome diagnosed on polysomnography or polygraphy performed less than 6 months ago with (AHI > 30/h and 80% of obstructive events) and (ODI 4% > 20 or time with SaO2 below 90% > 5%).
- Patient free from continuous positive airway pressure (CPAP) treatment or any other SAS treatment for at least 3 months
- Patient with no psychrotropic medication or stable psychotropic medication since the diagnostic polysomnography or polygraphy examination
- Patient was informed and has signed the informed consent
Exclusion Criteria:
Patients who meet any one of these criteria will be excluded from the study:
- Patients sleeping less than 4 hours per night
- Patients suffering from respiratory failure, such as chronic obstructive pulmonary disease (COPD), pneumonia, pulmonary edema, pulmonary fibrosis, asthma, pulmonary arterial hypertension.
- Patients developing periodic breathing or Cheyne Stokes respiration
- Obese patient (BMI>35kg/m2)
- Patient with autonomic dysfunction (symptoms include orthostatic hypotension, exercise intolerance, sweating abnormalities, digestion difficulties, urinary problems, vision problems) as complication of diabetes, Parkinson's disease or other primary pathologies.
- Patient suffering from restless leg syndrome or periodic leg movement (PLM) not related to obstructive sleep apnea, i.e. PLM index > 15/h excluding movements linked to respiratory events.
- Patient suffering from positional sleep apnea syndrome (SAS), i.e. supine apnea hypopnea index (AHI) at least twice that of the non-supine AHI
- Patient suffering from severe peripheral neuropathy
- Vulnerable patient in accordance with article L1121-6 of Code de la Santé Publique (CSP)
- Patient already involved in another clinical study that could affect the result of this study
- Pregnant patient
Sites / Locations
- Hospital Beziers
- University Hospital Grenoble
- CHU Rennes
- University Hospital Tours
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment ON
Treatment OFF
Arm Description
Kinesthetic stimulation administered during one night
NO kinesthetic stimulation administered during one night
Outcomes
Primary Outcome Measures
Rate of responder to the therapy
A patient is defined as 'responder' to the therapy by comparison of the treated night to the non-treated night based on:
The oxygen desaturation index (ODI)
The time spent below 90% of oxygen saturation or
The apnea hypopnea index (AHI) reduction
Secondary Outcome Measures
Adverse device effect
Adverse Events related to the investigational device
Effect on apneas/hypopneas duration
Therapy effect on shortening respiratory events
Effect on modified apnea hypopnea index
The modified apnea hypopnea indices (AHIs) will be compared between the treated and non-treated night and defined based on the duration of the respiratory disorders
Instantaneous heart rate measurement (bpm) during the night ON and the night OFF
Number of arousals per night - comparison night ON and night OFF
The micro-arousal index will be calculated on the polysomnography recording.
Effect on an objective measure of somnolence (Osler)
Osler test (optional) performed after treated night and non-treated night
Full Information
NCT ID
NCT02789748
First Posted
February 18, 2016
Last Updated
October 3, 2017
Sponsor
LivaNova
Collaborators
National Research Agency, France
1. Study Identification
Unique Protocol Identification Number
NCT02789748
Brief Title
PErsonalized and Adaptive Kinesthetic stImulation Therapy, Based on Cardio-respiratory Holter moNitoring, for Sleep Apnea syndrOmes
Acronym
EKINOx
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
June 1, 2016 (Actual)
Primary Completion Date
October 2, 2017 (Actual)
Study Completion Date
October 2, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LivaNova
Collaborators
National Research Agency, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims at quantifying the performance of kinesthetic stimulation to reduce the burden of obstructive sleep apneas and hypopneas.
Detailed Description
Severe sleep apnea patients will undergo two polysomnographies (PSG), one with kinesthetic stimulation triggered on the detection of apneas and hypopneas (treated night ) and the other without kinesthetic stimulation (non-treated night ). Comparison of apnea and hypopnea indices (AHI) and of oxygen saturation between the treated and non-treated night will be taken as indicators to quantify the performance of this potential new therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment ON
Arm Type
Experimental
Arm Description
Kinesthetic stimulation administered during one night
Arm Title
Treatment OFF
Arm Type
No Intervention
Arm Description
NO kinesthetic stimulation administered during one night
Intervention Type
Device
Intervention Name(s)
Kinesthetic stimulation
Intervention Description
Activation of mechanoreceptors by vibration bursts
Primary Outcome Measure Information:
Title
Rate of responder to the therapy
Description
A patient is defined as 'responder' to the therapy by comparison of the treated night to the non-treated night based on:
The oxygen desaturation index (ODI)
The time spent below 90% of oxygen saturation or
The apnea hypopnea index (AHI) reduction
Time Frame
Day 1 post-discharge
Secondary Outcome Measure Information:
Title
Adverse device effect
Description
Adverse Events related to the investigational device
Time Frame
Day 1 post-discharge
Title
Effect on apneas/hypopneas duration
Description
Therapy effect on shortening respiratory events
Time Frame
Day 1 post-discharge
Title
Effect on modified apnea hypopnea index
Description
The modified apnea hypopnea indices (AHIs) will be compared between the treated and non-treated night and defined based on the duration of the respiratory disorders
Time Frame
Day 1 post-discharge
Title
Instantaneous heart rate measurement (bpm) during the night ON and the night OFF
Time Frame
Day 1 post-discharge
Title
Number of arousals per night - comparison night ON and night OFF
Description
The micro-arousal index will be calculated on the polysomnography recording.
Time Frame
Day 1 post-discharge
Title
Effect on an objective measure of somnolence (Osler)
Description
Osler test (optional) performed after treated night and non-treated night
Time Frame
Day 1 post-discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who meet all the following criteria at the time of enrollment may be included:
Man or woman aged more than 18 years old.
Patient with severe obstructive apnea syndrome diagnosed on polysomnography or polygraphy performed less than 6 months ago with (AHI > 30/h and 80% of obstructive events) and (ODI 4% > 20 or time with SaO2 below 90% > 5%).
Patient free from continuous positive airway pressure (CPAP) treatment or any other SAS treatment for at least 3 months
Patient with no psychrotropic medication or stable psychotropic medication since the diagnostic polysomnography or polygraphy examination
Patient was informed and has signed the informed consent
Exclusion Criteria:
Patients who meet any one of these criteria will be excluded from the study:
Patients sleeping less than 4 hours per night
Patients suffering from respiratory failure, such as chronic obstructive pulmonary disease (COPD), pneumonia, pulmonary edema, pulmonary fibrosis, asthma, pulmonary arterial hypertension.
Patients developing periodic breathing or Cheyne Stokes respiration
Obese patient (BMI>35kg/m2)
Patient with autonomic dysfunction (symptoms include orthostatic hypotension, exercise intolerance, sweating abnormalities, digestion difficulties, urinary problems, vision problems) as complication of diabetes, Parkinson's disease or other primary pathologies.
Patient suffering from restless leg syndrome or periodic leg movement (PLM) not related to obstructive sleep apnea, i.e. PLM index > 15/h excluding movements linked to respiratory events.
Patient suffering from positional sleep apnea syndrome (SAS), i.e. supine apnea hypopnea index (AHI) at least twice that of the non-supine AHI
Patient suffering from severe peripheral neuropathy
Vulnerable patient in accordance with article L1121-6 of Code de la Santé Publique (CSP)
Patient already involved in another clinical study that could affect the result of this study
Pregnant patient
Facility Information:
Facility Name
Hospital Beziers
City
Beziers
ZIP/Postal Code
34500
Country
France
Facility Name
University Hospital Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
CHU Rennes
City
Rennes
Country
France
Facility Name
University Hospital Tours
City
Tours
ZIP/Postal Code
37 044
Country
France
12. IPD Sharing Statement
Learn more about this trial
PErsonalized and Adaptive Kinesthetic stImulation Therapy, Based on Cardio-respiratory Holter moNitoring, for Sleep Apnea syndrOmes
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