Effect of Inspiratory Muscle Training in Obstructive Sleep Apnea Syndrome.
NCT ID: NCT06117579
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
58 participants
INTERVENTIONAL
2024-06-26
2027-01-25
Brief Summary
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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.
Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
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.
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
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* OSA with an Apnea Hypopnea Index ≥ 5 requiring CPAP
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Centre Hospitalier Régional d'Orléans
OTHER
Responsible Party
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Principal Investigators
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Marie DEVAUX, Dr
Role: PRINCIPAL_INVESTIGATOR
CHU d'Orléans
Locations
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Chu Orleans
Orléans, , France
Countries
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Central Contacts
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Facility Contacts
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Marie DEVAUX
Role: primary
References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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CHRO-2023-08
Identifier Type: -
Identifier Source: org_study_id