Effect of Inspiratory Muscle Training in Obstructive Sleep Apnea Syndrome.

Study Overview
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Brief Summary
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Sleep apnea-hypopnea syndrome is a sleep-related respiratory disorder characterized by partial or total interruptions in breathing during sleep. The majority of syndromes involve an obstructive mechanism (OSA), caused by a reduction in the caliber of the upper airway (UA), most often associated with hypotonia of the surrounding muscles, preventing air from entering the UA during inspiration (1). The clinical consequences of this syndrome are excessive fatigue and daytime sleepiness, which have a negative impact on the quality of life of patients. (2,3) Despite the positive results on apnea-hypopnea index and daytime sleepiness of continuous positive airway pressure (today's reference treatment), its 3-year compliance rate (i.e 59.9% according to a study by Abdelghani et al (4) points to the need to develop other associated therapies. Several studies have demonstrated the efficacy of physiotherapy, such as physical activity and oro-pharyngeal muscle strengthening, notably on the apnea-hypopnea index and daytime sleepiness measured by the Epworth scale (5,6). Few studies have investigated the effect of inspiratory muscle training (IMT), even though the use of the inspiratory musculature (i.e. the diaphragm) is a means of supplementing the peri-pharyngeal muscles, as it helps to maintain the permeability of the upper airways (7-9). Inspiratory muscle training (IMT) could therefore be considered as part of the physiotherapeutic management of the OSA. The heterogeneity of current results concerning IMT in OSA , but above all the lack of evidence that it is dangerous, means that new clinical studies could be carried out in an attempt to demonstrate its efficacy. Our research hypothesis is therefore as follows: Implementing an inspiratory muscle strengthening protocol in patients suffering from OSA can reduce daytime sleepiness.

Official Title
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Effect of Inspiratory Muscle Training on Daytime Sleepiness in Obstructive Sleep Apnea Syndrome : Prospective Randomized Controlled Trial

Conditions
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Obstructive Sleep Apnea of Adult

Intervention / Treatment
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* Other: Inspiratory muscle training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients over 18 years of age with OSA with an Apnea Hypopnea Index ≥ 5 requiring CPAP Exclusion Criteria: Sleep apnea of neurological or mixed origin, Contraindication to or refusal of CPAP, Cognitive disorders, protected persons (under guardianship or curatorship), persons under court protection, persons not affiliated to a social security scheme pregnant or breast-feeding women.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inspiratory muscle training group<br>Step 1: During the consultation to diagnose obstructive sleep disorder with the pulmonologist (following polysomnography) to set up continuous positive airway pressure (CPAP): Introduction of CPAP Epworth Sleepiness Scale (ESS) Maximum Inspiratory Pressure (MIP) measurement Explanation of exercise program and use of POWERBreathe Step 2: 6-week telephone follow-up with measurement of Epworth Sleepiness Scale (ESS) Step 3: Follow-up visit at 12 weeks after introduction of CPAP: Review of CPAP implementation Epworth Sleepiness Scale (ESS) MIP measurement | Other: Inspiratory muscle training<br>* Description of a typical session: Session duration: between 12 and 20 minutes 3 cycles of 30 repetitions with 1 minute of break between each cycle. The patient should inhale as hard as possible against an inspiratory resistance generated by a valve device.<br>|
| No Intervention: Control group<br>Step 1: During the consultation to diagnose obstructive sleep disorder with the pulmonologist (following polysomnography) to set up continuous positive airway pressure (CPAP): Introduction of CPAP Epworth Sleepiness Scale (ESS) Maximum Inspiratory Pressure (MIP) measurement Step 2: 6-week telephone follow-up with measurement of Epworth Sleepiness Scale (ESS) Step 3: Follow-up visit at 12 weeks after introduction of CPAP: Review of CPAP implementation Epworth Sleepiness Scale (ESS) MIP measurement | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Daytime sleepiness | Change in daytime sleepiness measured by the Epworth Sleepiness Scale following the introduction of IMT combined with CPAP Epworth Sleepiness Scale ranged from 0 (it is unlikely that you are abnormally sleepy) to 24 (you are excessively sleepy and should consider seeking medical attention). | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obstructive Sleep Apnea, Inspiratory muscle training