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Completed

NCT Number: NCT04103073

Respiratory and Submental Muscles Activity During Inspiration and Expiration in Obstructive Sleep Apnea Syndrome

In this study respiratory and submental muscle activities during during inspiratory and expiratory breathing maneuver at specific workloads will be assessed according to inspiratory and expiratory muscle strength of each obstructive sleep apnea syndrome (OSAS) patient's.

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Key information

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hacettepe University, Faculty of Pyhsical Therapy and Rehabilitation

Ankara, Turkey (Türkiye)

About this study

Recurrent upper airway obstruction, apnea-hypopnea events, arousals and asphyxia during sleep increase the respiratory workload in patients with OSAS. This results in chronic overload of the inspiratory muscles -especially the diaphragm- and respiratory muscle fatigue in OSAS. When the literature was checked, there was no study assessing and comparing the activities of M. genioglossus, submental muscles (upper airways dilator muscles) and diaphragm during inspiration and expiration in a workload. Differences in the activity of these muscles according to the type of respiratory maneuver will provide more appropriate respiratory muscle training in patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Between 35-70 years old
  • Diagnosed with mild-moderate OSAS
  • Clinically stabile

Exclusion criteria

  • Anatomical obstructive upper airway
  • Occupations that lead to sleep deprivation or alterations in the sleep-wake cycle.
  • Comorbidities such as chronic obstructive pulmonary disease, asthma, interstitial lung diseases, neuromuscular diseases and psychiatric diseases

Treatment and study plan

Primary outcomes

  1. Pulmonary function test

    Time frame: about thirty minutes

    Pulmonary function will be assessed with a portable spirometer thorough the standard procedures. Pulmonary function test results will be recorded during the inspiratory and expiratory maneuver.

  2. Respiratory muscle strength

    Time frame: about thirty minutes

    Respiratory muscle strength will be measured with a respiratory pressure meter. Maximal inspiratory pressure and expiratory pressure were recorded.

  3. Surface electromyographic (sEMG) measurement of submental muscles and diaphragm

    Time frame: about thirty minutes

    Surface electromyographic (sEMG) activity of the submental muscle group (including the anterior belly of the digastric, mylohyoid, geniohyoid, and platysmas) and diaphragm will be measured during inspiratory and expiratory maneuver.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Assessment Respiratory and Submental Muscles Activity During Inspiratory and Expiratory Maneuver in Patients With Obstructive Sleep Apnea Syndrome

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 25, 2019
Registry last updated
Jan 20, 2022

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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