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NCT Number: NCT06471751

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Grenoble, Grenoble, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

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.

Primary outcomes

  1. Apnea-Hypopnea Index (AHI)

    Time frame: At 3 months

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

Secondary outcomes

  1. Maximum inspiratory pressure measurement (cmH2O)

    Time frame: At 3 and 9 Months

    Measured by POWERbreathe® K5

  2. Neck circumference (cm)

    Time frame: At 3 months

    The neck circumference is measured by Magnetic Resonance Imagery (RMI)

  3. Epworth sleepiness score

    Time frame: At 3 and 9 Months

    Sleep quality assessment using the Epworth sleepiness score. From 0 to 24. If score up to 10 then the patient has signs of excessive daytime sleepiness

  4. Pittsburgh Sleep quality index

    Time frame: At 3 and 9 Months

    Sleep quality assessment using the Pittsburgh Sleep quality index. From 0 to 21. Score 0 = very good sleep quality. Score 21 = very poor sleep quality

  5. Quality of life scale : Short Form 12 (SF12)

    Time frame: At 3 and 9 Months

    Quality of life assessment using the scale SF12 From 43 to 118 the higher the score, the better the quality of life

  6. PICOT fatigue scale

    Time frame: At 3 and 9 Months

    Fatigue assessment using the PICOT scale From 0 to 32 If score up to 22 then the patient has signs of excessive sleepiness

  7. AHI (Apnea-Hypopnea Index)

    Time frame: At 9 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Amandine ZELLAG, physiotherapist

CONTACT

[email protected]

(0)4 77 12 73 93 ext. +33

Pierre LABEIX, physiotherapist

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • Association aide à la recherche médicale de proximité (AIRE)
  • Conseil national de l'ordre des masseurs-kinésithérapeutes

Registry information

Acronym: REMI SAHOS

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 24, 2024
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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