Clinical Trial

Effect of Inspiratory Muscle Training in Obstructive Sleep Apnea Syndrome.

Study acronym: NOCTURNE
Recruiting
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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.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2023-10-31; most recent amendment 2025-12-22.
Status change: Not Yet Recruiting → Recruiting 2024-07-30
Trial Details
NCT Number NCT06117579
Lead Sponsor Centre Hospitalier Régional d'Orléans
Conditions Obstructive Sleep Apnea of Adult
Enrollment 58 participants
Start Date 2024-06-26
Primary Completion 2026-10-25 (estimated)
Study Completion 2027-01-25 (estimated)
Updated on ClinicalTrials.gov 2025-12-30