Effect of Inspiratory Muscle Training in Obstructive Sleep Apnea Syndrome.

Obstructive Sleep Apnea of Adult Clinical Trial

— NOCTURNE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06117579
• Other study ID #: CHRO-2023-08
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: January 1, 2026

Study information

• Verified date: March 2024
• Source: Centre Hospitalier Régional d'Orléans
• Contact: Aurelie DESPUJOLS, Msc
• Phone: +332 38 74 40 71
• Email: aurelie.despujols[@]chu-orleans.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 (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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 58
• Est. completion date: January 1, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea of Adult
• Respiratory Aspiration
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	Chu Orleans	Orléans

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional d'Orléans

Country where clinical trial is conducted

France, 

References & Publications (3)

Chou KT, Tsai YL, Yeh WY, Chen YM, Huang N, Cheng HM. Risk of work-related injury in workers with obstructive sleep apnea: A systematic review and meta-analysis. J Sleep Res. 2022 Feb;31(1):e13446. doi: 10.1111/jsr.13446. Epub 2021 Aug 12. — View Citation

Peng J, Yuan Y, Zhao Y, Ren H. Effects of Exercise on Patients with Obstructive Sleep Apnea: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2022 Aug 31;19(17):10845. doi: 10.3390/ijerph191710845. — View Citation

Sabil A, Bignard R, Gerves-Pinquie C, Philip P, Le Vaillant M, Trzepizur W, Meslier N, Gagnadoux F. Risk Factors for Sleepiness at the Wheel and Sleep-Related Car Accidents Among Patients with Obstructive Sleep Apnea: Data from the French Pays de la Loire Sleep Cohort. Nat Sci Sleep. 2021 Oct 5;13:1737-1746. doi: 10.2147/NSS.S328774. eCollection 2021. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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