NCT04103073

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 16, 2019

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2021

Completed
Last Updated

January 20, 2022

Status Verified

January 1, 2022

Enrollment Period

2 years

First QC Date

September 21, 2019

Last Update Submit

January 19, 2022

Conditions

Keywords

obstructive sleep apneaemginspiratory musclesexpiratory muscles

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

Age35 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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)

Location

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

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Haluk Tekerlek, MSc

    Hacettepe University

    PRINCIPAL INVESTIGATOR

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

Locations