Clinical trial NCT06471751: Strengthening Inspiratory and Oropharyngeal Muscles in Moderate Obstructive Sleep Apnea Hypopnea Syndrome
Official title: Strengthening Inspiratory and Oropharyngeal Muscles in Moderate Obstructive Sleep Apnea Hypopnea Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Inspiratory Muscles Training
Oropharyngeal training
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Association aide à la recherche médicale de proximité (AIRE)
name: Conseil national de l'ordre des masseurs-kinésithérapeutes
First posted: 2024-06-24
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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;

Primary outcomes:
measure: Apnea-Hypopnea Index (AHI)
timeFrame: At 3 months
Secondary outcomes:
measure: Maximum inspiratory pressure measurement (cmH2O)
timeFrame: At 3 and 9 Months
measure: Neck circumference (cm)
timeFrame: At 3 months
measure: Epworth sleepiness score
timeFrame: At 3 and 9 Months
measure: Pittsburgh Sleep quality index
timeFrame: At 3 and 9 Months
measure: Quality of life scale : Short Form 12 (SF12)
timeFrame: At 3 and 9 Months
measure: PICOT fatigue scale
timeFrame: At 3 and 9 Months
measure: AHI (Apnea-Hypopnea Index)
timeFrame: At 9 months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU de Grenoble
city: Saint-Étienne
country: France
facility: Centre Hospitalier Universitaire
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Amandine Zellag
role: PRINCIPAL_INVESTIGATOR
References: