Obstructive Sleep ApneaNCT04103073
Respiratory and Submental Muscles Activity During Inspiration and Expiration in Obstructive Sleep Apnea Syndrome
An observational study of Obstructive Sleep Apnea, run by Hacettepe University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Obstructive Sleep Apnea
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Sep 2019to 14 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Between 35-70 years old
- Diagnosed with mild-moderate OSAS
- Clinically stabile
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University, Faculty of Pyhsical Therapy and Rehabilitation
Ankara
About this study
Official title: Assessment Respiratory and Submental Muscles Activity During Inspiratory and Expiratory Maneuver in Patients With 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.
Read the detailed 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.
- Conditions
- Obstructive Sleep Apnea
- Keywords
- obstructive sleep apnea, emg, inspiratory muscles, expiratory muscles
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: about thirty minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start16 Sep 2019
- Primary completion14 Sep 2021
- Study completion14 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haluk TEKERLEK, Hacettepe University
- Investigators
- Haluk Tekerlek, MSc, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04103073
- Sponsor's protocol ID
- osasemg
- Status last verified
- Jan 2022
- First submitted
- 21 Sep 2019
- Last updated
- 20 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 17294298
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment Respiratory and Submental Muscles Activity During Inspiratory and Expiratory Maneuver in Patients With Obstructive Sleep Apnea Syndrome
- ClinicalTrials.gov ID
- NCT04103073
- Acronym / sponsor ID
- osasemg
- Conditions
- Obstructive Sleep Apnea
- Keywords
- obstructive sleep apnea, emg, inspiratory muscles, expiratory muscles
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 14 Sep 2021 (actual)
- Study completion
- 14 Dec 2021 (actual)
- First posted
- 25 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Between 35-70 years old
- Diagnosed with mild-moderate OSAS
- Clinically stabile
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2022.
- Background: PubMed 17294298Wheeler 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.
- Individual participant dataSharing planned: No
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haluk Tekerlek, MSc principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary function test (time frame: about thirty minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04103073, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2022.