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Obstructive Sleep Apnea Therapy by Stimulation of the Hypoglossal Nerve (AIRSTIM)

Primary Purpose

Obstructive Sleep Apnea Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Activated Inspire® Upper Airway Stimulation System
Inactivated Inspire® Upper Airway Stimulation System
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea Syndrome focused on measuring stimulation, hypoglossal nerve, Upper-airway

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient aged 18 to 80 years old
  • Patient with moderate to severe OSA based on an established diagnosis of OSA (15≤AHI<65) by polysomnography or respiratory polygraphy not older thant three years.
  • Patient with moderate to severe OSA naïve of treatment or with difficulty accepting or adhering to CPAP treatment.
  • Willing and capable to have stimulation hardware permanently implanted, and to use the patient programmer to activate the stimulation
  • Willing and capable to return for all follow-up visits and conduct sleep studies at home, including the evaluation procedures and filling out questionnaires
  • Willing and capable of providing written informed consent.

Exclusion Criteria:

  • Any anatomical finding that would compromise the performance of upper airway stimulation, such as the presence of complete concentric collapse of the soft palate
  • Have any condition or procedure that has compromised neurological control of the upper airway
  • Unable to operate the patient programmer
  • Pregnant or plan to become pregnant, and breastfeeding women
  • Require magnetic resonance imaging (MRI)
  • Have an implantable device that may be susceptible to unintended interaction with the Inspire system.

Additional exclusions for study purposes only

  • Body Mass Index (BMI) of >32
  • Central + mixed apneas > 25% of the total apnea-hypopnea index (AHI)
  • Neuromuscular disease
  • Hypoglossal-nerve palsy
  • Severe restrictive or obstructive pulmonary disease
  • Moderate-to-severe pulmonary arterial hypertension
  • Severe valvular heart disease
  • New York Heart Association class III or IV heart failure
  • Recent myocardial infarction or severe cardiac arrhythmias (within the past 6 months)
  • Persistent uncontrolled hypertension despite medication use
  • Coexisting nonrespiratory sleep disorders that would confound functional sleep assessment
  • Any chronic medical illness or condition that contraindicates a surgical procedure under general anesthesia, as judged by the clinical study Investigator
  • a terminal illness with life expectancy < 12 months
  • Active psychiatric disease (psychotic illness, major depression, or acute anxiety attacks) which prevents subject compliance with the requirements of the investigational study testing
  • Radiotherapy or ablation therapy of the head and/or neck
  • Surgical resection for cancer or congenital malformations in the larynx, tongue, or throat(with exception of tonsillectomy and/or adenoidectomy)
  • Previous surgery within 3 months performed on the soft-palate tissue
  • Obvious fixed upper airway obstructions (tumors, polyps, unilateral nasal obstruction)
  • Need for chronic supplemental oxygen therapy for any other reason, pO2 (partial pressure of oxygen) < 55 mm Hg
  • Clinical evidence of severe renal failure (Stage 4 or 5) undergoing dialysis or expected to institute dialysis within 6 months
  • Patients on medication that may alter consciousness, the pattern of respiration or sleep architecture (for example, benzodiazepiones, opiates, neuroleptics, prescription stimulants, phenothiazine, or any form of chemical substance abuse)
  • Patients taking blood thinning medications (for example warfarin, aspirin, plavix or other blood thinning agents which cannot be safety stopped or bridged temporarily to allow surgery to take place)
  • Any other reason for the investigator deems that the subject is unfit for participation in the study
  • Subject in exclusion period for another study
  • Subject under administrative or judicial control.

Sites / Locations

  • UniversityHospitalGrenobleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Activated Inspire® Upper Airway Stimulation System

Inactivated Inspire® Upper Airway Stimulation System

Arm Description

INSPIRE® device will be active a month

After a period 15 days of "wash-out" the INSPIRE® device will be inactivated for a second period of one month.

Outcomes

Primary Outcome Measures

Short-term efficacy of a new treatment for OSA on systolic blood pressure variability during sleep
Change in the difference between delta nocturnal systolic blood pressure (difference between maximum and minimal nocturnal systolic blood pressure ; nocturnal period is defined from 10 pm to 7am).

Secondary Outcome Measures

Short-term efficacy of a new treatment for OSA on mean-24h, daytime and nighttime blood pressure
Ambulatory 24h arterial blood pressure
Clinical efficacy of this new treatment on OSA by Epworth sleepiness scale score
It's a self-administered questionnaire with 8 questions. Patients are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person has daytime sleepiness.
Clinical efficacy of this new treatment on Apnea-Hypopnea Index measured by polysomnography
Apnea-Hypopnea Index expressed in number per hour
Change in sympatho-vagal balance based on heart rate variability analysis
ECG polysomnography
Self-reported changes in sleep and quality of life by SF-36 score
The SF-36 is a 36-item scale constructed to survey health status and quality of life (Ware & Sherbourne, 1992), assessing eight health concepts: limitations in Quality of life physical activities because of health problems; limitations in social activities because of physical or emotional problems; limitations in usual role activities because of physical health problems); bodily pain; general mental health (psychological distress and well-being); limitations in usual role activities because of emotional problems; vitality (energy and fatigue); and general health perceptions. The standard form of the instruments asks for participants to reply to questions according to how they have felt over the previous week. The items use Likert-type scales, some with 5 or 6 points and others with 2 or 3 points. The SF-36 has been widely used and has excellent psychometrics.
Sleep latency assessed during a Maintenance of Wakefulness Test
Mean sleep latency from the 4 sessions of the Maintenance of Wakefulness Test
Nocturnal pulse pressure assessed by Continuous Non-invasive Arterial Pressure monitoring
Pulse pressure variability indexe DeltaBP in mmHg.
Short-term efficacy of a new treatment for OSA on diastolic blood pressure variability during sleep
Change in the difference between delta nocturnal systolic blood pressure (difference between maximum and minimal nocturnal systolic blood pressure ; nocturnal period is defined from 10 pm to 7am).
Clinical efficacy of this new treatment on OSA by Pichot weakness scale score
It's a self-administered questionnaire with 8 questions. Patients are asked to rate, on a 5-point scale (0-4), their usual feeling of tiredness or weakness while engaged in eight different activities. The PWS score (the sum of 8 item scores, 0-4) can range from 0 to 32. The higher the PWS score, the higher that person has weakness.
Clinical efficacy of this new treatment on nocturia
Assessment of nocturia number by nigt
Clinical efficacy of this new treatment on morning asthenia
Patients are asked to assess, on a visual analogic scale morning asthenia. The items use a visual analogic scales from 0 to 10 points.
Clinical efficacy of this new treatment on morning headache
Patients are asked to assess, on a visual analogic scale morning headache. The items use a visual analogic scales from 0 to 10 points.
Clinical efficacy of this new treatment on snoring
Patients are asked to assess, on a visual analogic scale snoring. The items use a visual analogic scales from 0 to 10 points.
Self-reported changes in sleep and quality of life by FOSQ score
This is a disease specific quality of life questionnaire to determine functional status in adults; measures are designed to assess the impact of disorders of excessive sleepiness on multiple activities of everyday living and the extent to which these abilities are improved by effective treatment. The 5 domains that the FOSQ measures are as follows: Activity level, vigilance, intimacy and sexual relationships, general productivity, social outcome, rate the difficulty of performing a given activity on a 4-point scale (no difficulty to extreme difficulty).
Clinical efficacy of this new treatment on oxygen desaturation index measured by polysomnography
Oxygen desaturation index expressed in number
Clinical efficacy of this new treatment on sleep efficacy measured by polysomnography
Sleep efficacy expressed by ratio of total sleep time on total sleep period

Full Information

First Posted
October 18, 2018
Last Updated
June 3, 2022
Sponsor
University Hospital, Grenoble
Collaborators
Inspire Medical Systems, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03844295
Brief Title
Obstructive Sleep Apnea Therapy by Stimulation of the Hypoglossal Nerve
Acronym
AIRSTIM
Official Title
Upper AIRway Implanted Nerve STIMulation Therapy: A Breakthrough in Obstructive Sleep Apnea Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 21, 2019 (Actual)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
January 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
Collaborators
Inspire Medical Systems, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Continuous positive airway pressure (CPAP) is the gold standard to normalize breathing during sleep in patients with obstructive sleep apnea syndrom (OSA). Many patients will not tolerate or will not accept CPAP. Implanted nerve stimulation is a novel therapy for OSA patients that restores the upper airway potency using unilateral XII nerve electric stimulation. The principal objective of this study is short-term efficacy of a new treatment for OSA on blood pressure variability during sleep.
Detailed Description
Obstructive sleep apnea (OSA) syndrome had become over the last decade a serious health concern due to its high prevalence which raise 10% of the general population. It is characterized by recurrent episodes of airflow obstruction in the upper airway (UA) consequence of passive collapse of the UA, particularly at the tongue level. These collapses induce recurrent asphyxia that results in oxygen desaturations with persistant and crescendo respiratory efforts inducing arousals from sleep. Indeed, despite its large efficacy some of the patients will never accept continuous positive airway pressure treatment or will not tolerate. To this extent, alternative treatement has been developed: implanted hypoglossal stimulation. This treatment has been developed by Inspire Medical Device. The Inspire® system is intended to prevent base-of-tongue obstruction as well as specific soft palate obstructions by stimulating the hypoglossal nerve synchronous with respiration. A selection processus will be applied in order to identify the patients that will be good responders to the hypoglossal stimulation. The main criterion of selection is based on Drug Induced Sleep Endoscopy(DISE) that will be performed by a trained endoscopist dedicated to this study. This sleep endoscopy allows to visualize during induced sleep the shape of the UA and the type of collapsus. Indeed an antero-posterior collapsus is related to a good response to hypoglossal nerve stimulation while complete concentric obstruction at velopharyngeal is a predictor of poor response. In this pilot study, the investigators evaluate as a primary outcome the delta range of blood pressure during sleep but also other cardiovascular indexes targeting blood pressure and heart rate variability as secondary outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea Syndrome
Keywords
stimulation, hypoglossal nerve, Upper-airway

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Monocentric, prospective, controlled, patient single-blind study
Masking
Participant
Masking Description
Only patient will be blind. He doesn't know if INSPIRE therapy was activated or not
Allocation
Non-Randomized
Enrollment
6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Activated Inspire® Upper Airway Stimulation System
Arm Type
Experimental
Arm Description
INSPIRE® device will be active a month
Arm Title
Inactivated Inspire® Upper Airway Stimulation System
Arm Type
Placebo Comparator
Arm Description
After a period 15 days of "wash-out" the INSPIRE® device will be inactivated for a second period of one month.
Intervention Type
Device
Intervention Name(s)
Activated Inspire® Upper Airway Stimulation System
Intervention Description
At first, INSPIRE® device will be active a month
Intervention Type
Device
Intervention Name(s)
Inactivated Inspire® Upper Airway Stimulation System
Intervention Description
After 15 days "wash-out" INSPIRE® device will be inactivated for a second period of one month.
Primary Outcome Measure Information:
Title
Short-term efficacy of a new treatment for OSA on systolic blood pressure variability during sleep
Description
Change in the difference between delta nocturnal systolic blood pressure (difference between maximum and minimal nocturnal systolic blood pressure ; nocturnal period is defined from 10 pm to 7am).
Time Frame
one month treatment active versus non active treatment
Secondary Outcome Measure Information:
Title
Short-term efficacy of a new treatment for OSA on mean-24h, daytime and nighttime blood pressure
Description
Ambulatory 24h arterial blood pressure
Time Frame
one month treatment active versus non active treatment
Title
Clinical efficacy of this new treatment on OSA by Epworth sleepiness scale score
Description
It's a self-administered questionnaire with 8 questions. Patients are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person has daytime sleepiness.
Time Frame
one month treatment active versus non active treatment
Title
Clinical efficacy of this new treatment on Apnea-Hypopnea Index measured by polysomnography
Description
Apnea-Hypopnea Index expressed in number per hour
Time Frame
one month treatment active versus non active treatment
Title
Change in sympatho-vagal balance based on heart rate variability analysis
Description
ECG polysomnography
Time Frame
one month treatment active versus non active treatment
Title
Self-reported changes in sleep and quality of life by SF-36 score
Description
The SF-36 is a 36-item scale constructed to survey health status and quality of life (Ware & Sherbourne, 1992), assessing eight health concepts: limitations in Quality of life physical activities because of health problems; limitations in social activities because of physical or emotional problems; limitations in usual role activities because of physical health problems); bodily pain; general mental health (psychological distress and well-being); limitations in usual role activities because of emotional problems; vitality (energy and fatigue); and general health perceptions. The standard form of the instruments asks for participants to reply to questions according to how they have felt over the previous week. The items use Likert-type scales, some with 5 or 6 points and others with 2 or 3 points. The SF-36 has been widely used and has excellent psychometrics.
Time Frame
one month treatment active versus non active treatment
Title
Sleep latency assessed during a Maintenance of Wakefulness Test
Description
Mean sleep latency from the 4 sessions of the Maintenance of Wakefulness Test
Time Frame
one month treatment active versus non active treatment
Title
Nocturnal pulse pressure assessed by Continuous Non-invasive Arterial Pressure monitoring
Description
Pulse pressure variability indexe DeltaBP in mmHg.
Time Frame
one month treatment active versus non active treatment
Title
Short-term efficacy of a new treatment for OSA on diastolic blood pressure variability during sleep
Description
Change in the difference between delta nocturnal systolic blood pressure (difference between maximum and minimal nocturnal systolic blood pressure ; nocturnal period is defined from 10 pm to 7am).
Time Frame
one month treatment active versus non active treatment
Title
Clinical efficacy of this new treatment on OSA by Pichot weakness scale score
Description
It's a self-administered questionnaire with 8 questions. Patients are asked to rate, on a 5-point scale (0-4), their usual feeling of tiredness or weakness while engaged in eight different activities. The PWS score (the sum of 8 item scores, 0-4) can range from 0 to 32. The higher the PWS score, the higher that person has weakness.
Time Frame
one month treatment active versus non active treatment
Title
Clinical efficacy of this new treatment on nocturia
Description
Assessment of nocturia number by nigt
Time Frame
one month treatment active versus non active treatment
Title
Clinical efficacy of this new treatment on morning asthenia
Description
Patients are asked to assess, on a visual analogic scale morning asthenia. The items use a visual analogic scales from 0 to 10 points.
Time Frame
one month treatment active versus non active treatment
Title
Clinical efficacy of this new treatment on morning headache
Description
Patients are asked to assess, on a visual analogic scale morning headache. The items use a visual analogic scales from 0 to 10 points.
Time Frame
one month treatment active versus non active treatment
Title
Clinical efficacy of this new treatment on snoring
Description
Patients are asked to assess, on a visual analogic scale snoring. The items use a visual analogic scales from 0 to 10 points.
Time Frame
one month treatment active versus non active treatment
Title
Self-reported changes in sleep and quality of life by FOSQ score
Description
This is a disease specific quality of life questionnaire to determine functional status in adults; measures are designed to assess the impact of disorders of excessive sleepiness on multiple activities of everyday living and the extent to which these abilities are improved by effective treatment. The 5 domains that the FOSQ measures are as follows: Activity level, vigilance, intimacy and sexual relationships, general productivity, social outcome, rate the difficulty of performing a given activity on a 4-point scale (no difficulty to extreme difficulty).
Time Frame
one month treatment active versus non active treatment
Title
Clinical efficacy of this new treatment on oxygen desaturation index measured by polysomnography
Description
Oxygen desaturation index expressed in number
Time Frame
one month treatment active versus non active treatment
Title
Clinical efficacy of this new treatment on sleep efficacy measured by polysomnography
Description
Sleep efficacy expressed by ratio of total sleep time on total sleep period
Time Frame
one month treatment active versus non active treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient aged 18 to 80 years old Patient with moderate to severe OSA based on an established diagnosis of OSA (15≤AHI<65) by polysomnography or respiratory polygraphy not older thant three years. Patient with moderate to severe OSA naïve of treatment or with difficulty accepting or adhering to CPAP treatment. Willing and capable to have stimulation hardware permanently implanted, and to use the patient programmer to activate the stimulation Willing and capable to return for all follow-up visits and conduct sleep studies at home, including the evaluation procedures and filling out questionnaires Willing and capable of providing written informed consent. Exclusion Criteria: Any anatomical finding that would compromise the performance of upper airway stimulation, such as the presence of complete concentric collapse of the soft palate Have any condition or procedure that has compromised neurological control of the upper airway Unable to operate the patient programmer Pregnant or plan to become pregnant, and breastfeeding women Require magnetic resonance imaging (MRI) Have an implantable device that may be susceptible to unintended interaction with the Inspire system. Additional exclusions for study purposes only Body Mass Index (BMI) of >32 Central + mixed apneas > 25% of the total apnea-hypopnea index (AHI) Neuromuscular disease Hypoglossal-nerve palsy Severe restrictive or obstructive pulmonary disease Moderate-to-severe pulmonary arterial hypertension Severe valvular heart disease New York Heart Association class III or IV heart failure Recent myocardial infarction or severe cardiac arrhythmias (within the past 6 months) Persistent uncontrolled hypertension despite medication use Coexisting nonrespiratory sleep disorders that would confound functional sleep assessment Any chronic medical illness or condition that contraindicates a surgical procedure under general anesthesia, as judged by the clinical study Investigator a terminal illness with life expectancy < 12 months Active psychiatric disease (psychotic illness, major depression, or acute anxiety attacks) which prevents subject compliance with the requirements of the investigational study testing Radiotherapy or ablation therapy of the head and/or neck Surgical resection for cancer or congenital malformations in the larynx, tongue, or throat(with exception of tonsillectomy and/or adenoidectomy) Previous surgery within 3 months performed on the soft-palate tissue Obvious fixed upper airway obstructions (tumors, polyps, unilateral nasal obstruction) Need for chronic supplemental oxygen therapy for any other reason, pO2 (partial pressure of oxygen) < 55 mm Hg Clinical evidence of severe renal failure (Stage 4 or 5) undergoing dialysis or expected to institute dialysis within 6 months Patients on medication that may alter consciousness, the pattern of respiration or sleep architecture (for example, benzodiazepiones, opiates, neuroleptics, prescription stimulants, phenothiazine, or any form of chemical substance abuse) Patients taking blood thinning medications (for example warfarin, aspirin, plavix or other blood thinning agents which cannot be safety stopped or bridged temporarily to allow surgery to take place) Any other reason for the investigator deems that the subject is unfit for participation in the study Subject in exclusion period for another study Subject under administrative or judicial control.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Renaud RT TAMISIER, PhD
Phone
04 76 76 84 69
Ext
+33
Email
RTamisier@chu-grenoble.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Florence FB BOURCIER
Phone
04 76 76 79 00
Ext
+33
Email
FBourcier@chu-grenoble.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renaud RT TAMISIER, PhD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
UniversityHospitalGrenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renaud Tamisier, MD
Phone
+33 476768469
Email
rtamisier@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
Steffy MASUCCO, MS
Phone
+33 476767167
Email
smasucco@chu-grenoble.fr

12. IPD Sharing Statement

Plan to Share IPD
No
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Obstructive Sleep Apnea Therapy by Stimulation of the Hypoglossal Nerve

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