Strengthening Inspiratory and Oropharyngeal Muscles in Moderate Obstructive Sleep Apnea Hypopnea Syndrome

NCT06471751 | Recruiting

• 2 other identifiers: 23GI0192024-A00601-46
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

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.

Conditions

Obstructive Sleep Apnea

Keywords

Inspiratory Muscles Training; Oropharyngeal training

Outcome Measures

Primary Outcomes (1)

• Apnea-Hypopnea Index (AHI)

  AHI is measured by polygraphy or polysomnography. It is not a score

  At 3 months

Secondary Outcomes (7)

• Maximum inspiratory pressure measurement (cmH2O)

  At 3 and 9 Months

• Neck circumference (cm)

  At 3 months

• Epworth sleepiness score

  At 3 and 9 Months

• Pittsburgh Sleep quality index

  At 3 and 9 Months

• Quality of life scale : Short Form 12 (SF12)

  At 3 and 9 Months

Study Arms (2)

Strengthening muscles group

EXPERIMENTAL

Home training to strengthen Inspiratory and Oropharyngeal muscles

Other: Inspiratory and Oropharyngeal Muscle Strengthening

No training group

NO INTERVENTION

No intervention

Interventions

Inspiratory and Oropharyngeal Muscle Strengthening OTHER

Patients will conduct the training at home, 5 days a week for 3 months. They will perform 2 sets of 30 inspirations against resistance (POWERbreathe® K5 , Powerbreathe International Limited, UK), equal to 70% Maximum Inspiratory Pressure (MIP). Patients will be guided for oropharyngeal exercises. The sessions will be supervised by the investigator every 3 weeks. During sessions with the investigator, sessions recorded in the device will be downloaded to verify compliance. A MIP measurement will be performed to adjust the resistance of the device.

Strengthening muscles group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Association aide à la recherche médicale de proximité (AIRE): collaborator
• Conseil national de l'ordre des masseurs-kinésithérapeutes: collaborator

Study Sites (2)

CHU de Grenoble

Grenoble, 38000, France

NOT YET RECRUITING

Centre Hospitalier Universitaire

Saint-Etienne, 42055, France

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Inhalation

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Amandine Zellag

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amandine ZELLAG, physiotherapist

CONTACT

(0)4 77 12 73 93; amandine.zellag@chu-st-etienne.fr

Pierre LABEIX, physiotherapist

CONTACT

pierre.labeix@chu-st-etienne.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: June 24, 2024
• Study Start: December 30, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 29, 2025

Record last verified: 2025-01

Locations

FR (2)