Respiratory and Submental Muscles Activity During Inspiration and Expiration in Obstructive Sleep Apnea Syndrome
Assessment Respiratory and Submental Muscles Activity During Inspiratory and Expiratory Maneuver in Patients With Obstructive Sleep Apnea Syndrome
1 other identifier
observational
20
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 16, 2019
CompletedFirst Submitted
Initial submission to the registry
September 21, 2019
CompletedFirst Posted
Study publicly available on registry
September 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 14, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 14, 2021
CompletedJanuary 20, 2022
January 1, 2022
2 years
September 21, 2019
January 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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
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
Study Arms (1)
Study group
The patient with OSAS 35-70 years of age, clinically stabile, symptoms such as snoring, breathing cessations, and daytime sleepiness, and polysomnographic evidence consistent with mild (5\<apnea hypopnea index (AHI)\< 15) to moderate (16 \< AHI \< 30) OSAS.
Eligibility Criteria
Patients with OSAS who will be referred to the Cardiopulmonary Rehabilitation Unit of the Faculty of Physical Therapy and Rehabilitation of Hacettepe University by Dışkapı Yıldırım Beyazıt Educational and Research Hospital Department of Chest Diseases will be included in this study.
You may qualify if:
- Between 35-70 years old
- Diagnosed with mild-moderate OSAS
- Clinically stabile
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hacettepe University, Faculty of Pyhsical Therapy and Rehabilitation
Ankara, Turkey (Türkiye)
Related 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. doi: 10.1007/s00455-006-9061-4. Epub 2007 Feb 10.
PMID: 17294298BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Haluk Tekerlek, MSc
Hacettepe University
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research assistant
Study Record Dates
First Submitted
September 21, 2019
First Posted
September 25, 2019
Study Start
September 16, 2019
Primary Completion
September 14, 2021
Study Completion
December 14, 2021
Last Updated
January 20, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share