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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04103073
• Other study ID #: osasemg
• Status: Completed
• Start date: September 16, 2019
• Est. completion date: December 14, 2021

Study information

• Verified date: January 2022
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 14, 2021
• Est. primary completion date: September 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
Turkey	Hacettepe University, Faculty of Pyhsical Therapy and Rehabilitation	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Wheeler KM, Chiara T, Sapienza CM. Surface electromyographic activity of the submental muscles during swallow and expiratory pressure threshold training tasks. Dysphagia. 2007 Apr;22(2):108-16. Epub 2007 Feb 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary function test	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.	about thirty minutes
Primary	Respiratory muscle strength	Respiratory muscle strength will be measured with a respiratory pressure meter. Maximal inspiratory pressure and expiratory pressure were recorded.	about thirty minutes
Primary	Surface electromyographic (sEMG) measurement of submental muscles and diaphragm	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.	about thirty minutes