Obstructive Sleep ApneaREMI SAHOSNCT06471751
Strengthening Inspiratory and Oropharyngeal Muscles in Moderate Obstructive Sleep Apnea Hypopnea Syndrome
A study testing Inspiratory and Oropharyngeal Muscle Strengthening in people with Obstructive Sleep Apnea, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.
Trial summary
The Obstructive Sleep Apnea hypopnea Syndrome (OSAS), whose prevalence is 4% of the French population, can lead to serious health consequences (risk of road accidents, onset of cardiovascular disease, etc.). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Inspiratory and Oropharyngeal Muscle Strengthening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 2 sitesFrance
- Study dates
- 30 Dec 2024to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate SAHOS (15 ≤ AHI ≤30);
- Body Mass Index (BMI) < 35 ;
- Patient affiliated or entitled to a social security scheme;
- Patient having signed a consent to participate in the study.
Who cannot join
- Excessive daytime sleepiness: Epworth sleepiness score > 10 ;
- Professional driving and history of accidents related to sleepiness;
- Severe obstructive or restrictive ventilatory disorders of neuromuscular origin authenticated by respiratory function tests;
- Patients undergoing treatment for OSAS or requiring immediate initiation of continuous positive airway pressure (CPAP) or a mandibular advancement orthosis;
- Patients who have stopped CPAP or orthosis treatment in less than one month;
- Patients undergoing cardiorespiratory exercise rehabilitation or starting regular physical training;
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- Uncompensated heart failure, thoracic sternotomy surgery < 4 months;
- Marked osteoporosis with history of rib fractures;
- History of spontaneous pneumothorax;
- Severe asthma;
- Perforated eardrum or any other ear condition;
- Pulmonary hypertension;
- History of pharyngeal surgery to treat sleep apnea;
- Pregnant women or women in labor;
- Individuals deprived of their liberty or hospitalized without consent;
- Adults subject to legal protective measures (guardianship or conservatorship).
- Contraindications for MRI
- Patient with claustrophobia;
- Patient for whom MRI is contraindicated (pacemaker, metallic heart valve, metallic foreign body in the eye).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Pierre LABEIX, physiotherapist contact
France2 sites, 2 recruiting
- Not yet recruiting
CHU de Grenoble
Grenoble, 38000
Sébastien BAILLIEUL, MD
- Recruiting
Centre Hospitalier Universitaire
Saint-Etienne, 42055
Amandine ZELLAG, physiotherapist
Pierre LABEIX, physiotherapist
About this study
The Obstructive Sleep Apnea hypopnea Syndrome (OSAS), whose prevalence is 4% of the French population, can lead to serious health consequences (risk of road accidents, onset of cardiovascular disease, etc.). OSAS corresponds to a certain number of interruptions (apneas) or reductions (hypopneas) of ventilation during sleep. The weakening of the tone of the inspiratory and oropharyngeal muscles is one of the main causes of upper airways obstruction during the inspiratory phase.
Read the detailed description
For patients with moderate OSAS, with few or no symptoms, without associated cardiovascular comorbidities, there is no recommended treatment. Rehabilitate the inspiratory and oropharyngeal muscles through muscle strengthening seems to be an alternative to this problem. Therefore, this study proposes a complete rehabilitation care evaluating the effectiveness of the strengthening of inspiratory and oropharyngeal muscles in subject with moderate OSAS.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Inspiratory and Oropharyngeal Muscle Strengthening
- Keywords
- Inspiratory Muscles Training, Oropharyngeal training
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory and Oropharyngeal Muscle StrengtheningOther
Patients will conduct the training at home, 5 days a week for 3 months. They will perform 2 sets of 30 inspirations against resistance (POWERbreathe® K5 , Powerbreathe International Limited, UK), equal to 70% Maximum Inspiratory Pressure (MIP). Patients will be guided for oropharyngeal exercises.
The sessions will be supervised by the investigator every 3 weeks. During sessions with the investigator, sessions recorded in the device will be downloaded to verify compliance. A MIP measurement will be performed to adjust the resistance of the device.
| Study group | Role | What they receive |
|---|---|---|
| Strengthening muscles group | Experimental | Home training to strengthen Inspiratory and Oropharyngeal muscles Receives: Other: Inspiratory and Oropharyngeal Muscle Strengthening |
| No training group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-Hypopnea Index (AHI)
AHI is measured by polygraphy or polysomnography. It is not a score
Measured: At 3 months
Secondary outcomes (7)
Maximum inspiratory pressure measurement (cmH2O)
Measured by POWERbreathe® K5
Measured: At 3 and 9 Months
Neck circumference (cm)
The neck circumference is measured by Magnetic Resonance Imagery (RMI)
Measured: At 3 months
Epworth sleepiness score
Sleep quality assessment using the Epworth sleepiness score. From 0 to 24. If score up to 10 then the patient has signs of excessive daytime sleepiness
Measured: At 3 and 9 Months
Pittsburgh Sleep quality index
Sleep quality assessment using the Pittsburgh Sleep quality index. From 0 to 21. Score 0 = very good sleep quality. Score 21 = very poor sleep quality
Measured: At 3 and 9 Months
Quality of life scale : Short Form 12 (SF12)
Quality of life assessment using the scale SF12 From 43 to 118 the higher the score, the better the quality of life
Measured: At 3 and 9 Months
PICOT fatigue scale
Fatigue assessment using the PICOT scale From 0 to 32 If score up to 22 then the patient has signs of excessive sleepiness
Measured: At 3 and 9 Months
AHI (Apnea-Hypopnea Index)
AHI is measured by polygraphy or polysomnography It is not a score
Measured: At 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start30 Dec 2024
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Association aide à la recherche médicale de proximité (AIRE), Conseil national de l'ordre des masseurs-kinésithérapeutes
- Responsible party
- Sponsor
- Investigators
- Amandine Zellag, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06471751
- Sponsor's protocol ID
- 23GI019
- Other IDs
- 2024-A00601-46
- Acronym
- REMI SAHOS
- Status last verified
- Sep 2026
- First submitted
- 18 Jun 2024
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strengthening Inspiratory and Oropharyngeal Muscles in Moderate Obstructive Sleep Apnea Hypopnea Syndrome
- ClinicalTrials.gov ID
- NCT06471751
- Acronym / sponsor ID
- REMI SAHOS / 23GI019
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Inspiratory Muscles Training, Oropharyngeal training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Association aide à la recherche médicale de proximité (AIRE), Conseil national de l'ordre des masseurs-kinésithérapeutes
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 24 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Obstructive Sleep Apnea hypopnea Syndrome (OSAS), whose prevalence is 4% of the French population, can lead to serious health consequences (risk of road accidents, onset of cardiovascular disease, etc.). OSAS corresponds to a certain number of interruptions (apneas) or reductions (hypopneas) of ventilation during sleep. The weakening of the tone of the inspiratory and oropharyngeal muscles is one of the main causes of upper airways obstruction during the inspiratory phase.
Detailed description
For patients with moderate OSAS, with few or no symptoms, without associated cardiovascular comorbidities, there is no recommended treatment. Rehabilitate the inspiratory and oropharyngeal muscles through muscle strengthening seems to be an alternative to this problem. Therefore, this study proposes a complete rehabilitation care evaluating the effectiveness of the strengthening of inspiratory and oropharyngeal muscles in subject with moderate OSAS.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strengthening muscles group | Experimental | Other: Inspiratory and Oropharyngeal Muscle StrengtheningHome training to strengthen Inspiratory and Oropharyngeal muscles |
| No training group | No intervention | –No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Moderate SAHOS (15 ≤ AHI ≤30);
- Body Mass Index (BMI) < 35 ;
- Patient affiliated or entitled to a social security scheme;
- Patient having signed a consent to participate in the study.
Key exclusion criteria (19 listed)
- Excessive daytime sleepiness: Epworth sleepiness score > 10 ;
- Professional driving and history of accidents related to sleepiness;
- Severe obstructive or restrictive ventilatory disorders of neuromuscular origin authenticated by respiratory function tests;
- Patients undergoing treatment for OSAS or requiring immediate initiation of continuous positive airway pressure (CPAP) or a mandibular advancement orthosis;
- Patients who have stopped CPAP or orthosis treatment in less than one month;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory and Oropharyngeal Muscle StrengtheningPatients will conduct the training at home, 5 days a week for 3 months. They will perform 2 sets of 30 inspirations against resistance (POWERbreathe® K5 , Powerbreathe International Limited, UK), equal to 70% Maximum Inspiratory Pressure (MIP). Patients will be guided for oropharyngeal exercises. The sessions will be supervised by the investigator every 3 weeks. During sessions with the investigator, sessions recorded in the device will be downloaded to verify compliance. A MIP measurement will be performed to adjust the resistance of the device. | Other | Strengthening muscles group |
Primary outcome
Apnea-Hypopnea Index (AHI)
Time frame: At 3 months
AHI is measured by polygraphy or polysomnography. It is not a score
7 secondary outcomes
Maximum inspiratory pressure measurement (cmH2O)
Time frame: At 3 and 9 Months
Neck circumference (cm)
Time frame: At 3 months
Epworth sleepiness score
Time frame: At 3 and 9 Months
Pittsburgh Sleep quality index
Time frame: At 3 and 9 Months
Quality of life scale : Short Form 12 (SF12)
Time frame: At 3 and 9 Months
PICOT fatigue scale
Time frame: At 3 and 9 Months
AHI (Apnea-Hypopnea Index)
Time frame: At 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pierre LABEIX, physiotherapist contact
Amandine Zellag principal investigator
Centre Hospitalier Universitaire de Saint Etienne
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory and Oropharyngeal Muscle Strengthening in people with Obstructive Sleep Apnea, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amandine ZELLAG, physiotherapist ((0)4 77 12 73 93 ext. +33, amandine.zellag@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea-Hypopnea Index (AHI) (time frame: At 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.