Effect of Inspiratory Muscle Training in Obstructive Sleep Apnea Syndrome.

NCT06117579 | Recruiting

• 1 other identifier: CHRO-2023-08
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obstructive Sleep Apnea of Adult

Keywords

Obstructive Sleep Apnea; Inspiratory muscle training

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Inspiratory muscle training group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

Inspiratory muscle training OTHER

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.

Inspiratory muscle training group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients over 18 years of age with
• OSA with an Apnea Hypopnea Index ≥ 5 requiring CPAP

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (1)

Chu Orleans

Orléans, France

RECRUITING

Related Publications (6)

• 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.

  PMID: 34384138 BACKGROUND

• 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.

  PMID: 34675722 BACKGROUND

• 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.

  PMID: 36078558 BACKGROUND

• Abdelghani A, Slama S, Hayouni A, Harrabi I, Mezghanni S, Garrouche A, Klabi N, Benzarti M, Jerray M. [Acceptance and long-term compliance to continuous positive airway pressure in obstructive sleep apnea. A prospective study on 72 patients treated between 2004 and 2007]. Rev Pneumol Clin. 2009 Jun;65(3):147-52. doi: 10.1016/j.pneumo.2009.03.010. Epub 2009 Jun 3. French.

  PMID: 19524803 BACKGROUND

• Azeredo LM, Souza LC, Guimaraes BLS, Puga FP, Behrens NSCS, Lugon JR. Inspiratory muscle training as adjuvant therapy in obstructive sleep apnea: a randomized controlled trial. Braz J Med Biol Res. 2022 Oct 3;55:e12331. doi: 10.1590/1414-431X2022e12331. eCollection 2022.

  PMID: 36197415 BACKGROUND

• Eckert DJ, White DP, Jordan AS, Malhotra A, Wellman A. Defining phenotypic causes of obstructive sleep apnea. Identification of novel therapeutic targets. Am J Respir Crit Care Med. 2013 Oct 15;188(8):996-1004. doi: 10.1164/rccm.201303-0448OC.

  PMID: 23721582 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Marie DEVAUX, Dr

  CHU d'Orléans

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aurelie DESPUJOLS, Msc

CONTACT

+332 38 74 40 71; aurelie.despujols@chu-orleans.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 7, 2023
• Study Start: June 26, 2024
• Primary Completion (Estimated): October 25, 2026
• Study Completion (Estimated): January 25, 2027
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)