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Strengthening Inspiratory and Oropharyngeal Muscles in Moderate Obstructive Sleep Apnea Hypopnea Syndrome (REMI SAHOS)

C

Centre Hospitalier Universitaire de Saint Etienne

Status

Enrolling

Conditions

Obstructive Sleep Apnea

Treatments

Other: Inspiratory and Oropharyngeal Muscle Strengthening

Study type

Interventional

Funder types

Other

Identifiers

NCT06471751
2024-A00601-46 (Other Identifier)
23GI019

Details and patient eligibility

About

The Obstructive Sleep Apnea hypopnea Syndrome (OSAS), whose prevalence is 4% of the French population, can lead to serious health consequences (risk of road accidents, onset of cardiovascular disease, etc.). OSAS corresponds to a certain number of interruptions (apneas) or reductions (hypopneas) of ventilation during sleep. The weakening of the tone of the inspiratory and oropharyngeal muscles is one of the main causes of upper airways obstruction during the inspiratory phase.

Full description

For patients with moderate OSAS, with few or no symptoms, without associated cardiovascular comorbidities, there is no recommended treatment. Rehabilitate the inspiratory and oropharyngeal muscles through muscle strengthening seems to be an alternative to this problem. Therefore, this study proposes a complete rehabilitation care evaluating the effectiveness of the strengthening of inspiratory and oropharyngeal muscles in subject with moderate OSAS.

Enrollment

38 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Moderate SAHOS (15 ≤ AHI ≤30);
  • Body Mass Index (BMI) < 35 ;
  • Patient affiliated or entitled to a social security scheme;
  • Patient having signed a consent to participate in the study.

Exclusion criteria

  • Excessive daytime sleepiness: Epworth sleepiness score > 10 ;
  • Professional driving and history of accidents related to sleepiness;
  • Severe obstructive or restrictive ventilatory disorders of neuromuscular origin authenticated by respiratory function tests;
  • Patients undergoing treatment for OSAS or requiring immediate initiation of continuous positive airway pressure (CPAP) or a mandibular advancement orthosis;
  • Patients who have stopped CPAP or orthosis treatment in less than one month;
  • Patients undergoing cardiorespiratory exercise rehabilitation or starting regular physical training;
  • Uncompensated heart failure, thoracic sternotomy surgery < 4 months;
  • Marked osteoporosis with history of rib fractures;
  • History of spontaneous pneumothorax;
  • Severe asthma;

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

38 participants in 2 patient groups

Strengthening muscles group
Experimental group
Description:
Home training to strengthen Inspiratory and Oropharyngeal muscles
Treatment:
Other: Inspiratory and Oropharyngeal Muscle Strengthening
No training group
No Intervention group
Description:
No intervention

Trial contacts and locations

2

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Central trial contact

Amandine ZELLAG, physiotherapist; Pierre LABEIX, physiotherapist

Data sourced from clinicaltrials.gov

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