Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06117579

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

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

58

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Obstructive sleep apnea (OSA) is a sleep disorder marked by partial or complete pauses in breathing during sleep, often caused by a narrowing of the upper airway and muscle weakness. This condition leads to excessive tiredness and daytime sleepiness, affecting patients' quality of life. While the standard treatment, continuous positive airway pressure (CPAP), improves symptoms, its long-term use compliance is limited, highlighting the need for additional therapies. Researchers are exploring inspiratory muscle training (IMT), which strengthens muscles like the diaphragm to help keep airways open, as a potential supportive treatment for OSA. The study compares two groups: one receiving inspiratory muscle training along with CPAP and one receiving CPAP alone. IMT sessions last 12 to 20 minutes and include three cycles of 30 breaths against resistance using a valve device, with breaks between cycles. Participants will start CPAP treatment and undergo assessments including the Epworth Sleepiness Scale and maximum inspiratory pressure measurement. Follow-up includes a six-week phone check and a visit at 12 weeks to review CPAP use and repeat assessments. Participants will be evaluated at diagnosis and during follow-up visits with questionnaires and pressure measurements to monitor daytime sleepiness and respiratory muscle strength. Researchers measure changes in daytime sleepiness after 12 weeks as the main outcome. The study involves regular monitoring through consultations and phone calls over 12 weeks, with safety and treatment adherence tracked to understand the impact of adding inspiratory muscle training to standard CPAP therapy.

CONDITIONS

Brief 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
  • Diagnosis of obstructive sleep apnea with an Apnea Hypopnea Index of 5 or more
  • Requirement for continuous positive airway pressure (CPAP) treatment
Not Eligible

You will not qualify if you...

  • Sleep apnea of neurological or mixed origin
  • Contraindication to or refusal of CPAP
  • Cognitive disorders
  • Persons under guardianship, curatorship, or court protection
  • Persons not affiliated with a social security scheme
  • Pregnant or breastfeeding women

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) during consultation to diagnose obstructive sleep disorder with the pulmonologist following polysomnography

Treatment

Duration - 12 weeks

Participants receive inspiratory muscle training alongside continuous positive airway pressure (CPAP) treatment to reduce daytime sleepiness caused by obstructive sleep apnea.

6-week telephone follow-up and a follow-up visit at 12 weeks after CPAP introduction

Trial Site Locations

Total: 1 location

1

Chu Orleans

Orléans, France

Actively Recruiting

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Research Team

A

Aurelie DESPUJOLS, Msc

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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Published Research Related To This Trial

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.

AbdelKebir Sabil, Remi Bignard, Chloé Gervès-Pinquié...

https://pubmed.ncbi.nlm.nih.gov/34675722

[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].

A Abdelghani, S Slama, A Hayouni...

https://pubmed.ncbi.nlm.nih.gov/19524803