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Clinical Trials in France / NCT06117579
Recruiting Not applicable

Effect of Inspiratory Muscle Training in Obstructive Sleep Apnea Syndrome.

NCT06117579 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2024-06-26
Last updated
2025-12-30

Condition(s) studied

Obstructive Sleep Apnea of Adult

Investigational drug(s) / intervention(s)

Inspiratory muscle training

Inspiratory muscle training: 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.

Study summary

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. The clinical consequences of this syndrome are excessive fatigue and daytime sleepiness, which have a negative impact on the quality of life of patients.

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 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.

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. 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Chu Orleans Orléans France Recruiting

More Centre Hospitalier Régional d'Orléans trials in France

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06117579 on ClinicalTrials.gov ↗ ← All trials in France