Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06117579

Effect of Inspiratory Muscle Training in Obstructive Sleep Apnea Syndrome.

Led by Centre Hospitalier Régional d'Orléans · Updated on 2025-12-30

58

Participants Needed

1

Research Sites

134 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Effect of Inspiratory Muscle Training in Obstructive Sleep Apnea Syndrome.

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients over 18 years of age
  • Diagnosed with obstructive sleep apnea with an Apnea Hypopnea Index of 5 or higher
  • Requiring continuous positive airway pressure (CPAP) treatment
Not Eligible

You will not qualify if you...

  • Sleep apnea due to neurological or mixed causes
  • Contraindication to or refusal of CPAP therapy
  • Cognitive disorders
  • Being under legal protection such as guardianship or curatorship
  • Not affiliated with a social security scheme
  • Pregnant or breastfeeding women

AI-Screening

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Trial Site Locations

Total: 1 location

1

Chu Orleans

Orléans, France

Actively Recruiting

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Research Team

A

Aurelie DESPUJOLS, Msc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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