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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• patients over 18 years of age with

• OSA with an Apnea Hypopnea Index ≥ 5 requiring CPAP

Locations
Other Locations
France
Chu Orleans
RECRUITING
Orléans
Contact Information
Primary
Aurelie DESPUJOLS, Msc
aurelie.despujols@chu-orleans.fr
+332 38 74 40 71
Time Frame
Start Date: 2024-06-26
Estimated Completion Date: 2026-01-01
Participants
Target number of participants: 58
Treatments
Experimental: Inspiratory muscle training group
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
No_intervention: Control group
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
Related Therapeutic Areas
Sponsors
Leads: Centre Hospitalier Régional d'Orléans

This content was sourced from clinicaltrials.gov

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