Sleep Apnea SyndromesOSASMumecPRONCT04858399
Muscle Tone Change in Obstructive Sleep Apnea
An observational study of Sleep Apnea Syndromes, run by Bitlis Eren University at 1 site in Turkey (Türkiye).
Trial summary
The study aim of the project is to investigate the differences in respiratory functions, orofacial muscle tone changes, anxiety/depression, and quality of life of the patients according to the severity of Obstructive Sleep Apnea Syndrome. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sleep Apnea Syndromes
- What is being tested?
- Evaluation
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Apr 2021to 30 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic in Bitlis.
Who may be able to join
- Age > 18 years old.
- Getting a diagnosis of OSAS with polysomnography.
- Agree to participate in the study.
Who cannot join
- Having respiratory system disease (COPD, asthma, bronchiectasis, lung cancer, etc.).
- Sedative, hypnotic drug intake. Use of medical supplements such as diazepam.
- Hypothyroidism, acromegaly.
- Diagnosis of a psychiatric illness.
- Uncontrolled arrhythmia causing symptoms or hemodynamic impairment.
- Pulmonary edema.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examination of Orofacial Muscles With Myotonometer in Obstructive Sleep Apnea Syndrome and Investigation of the Risk of Exposure According to Disease Severity
The study aim of the project is to investigate the differences in respiratory functions, orofacial muscle tone changes, anxiety/depression, and quality of life of the patients according to the severity of Obstructive Sleep Apnea Syndrome. At the same time, to examine the reliability of the use of the MyotonPro evaluation method, which takes place rapidly in the literature and clinic, in the orofacial pharyngeal muscle group.
Read the detailed description
Obstructive sleep apnea (OSA) syndrome is a common but often unrecognized disorder caused by pharyngeal collapse during sleep and characterized by frequent awakenings, disrupted sleep, and consequent excessive daytime sleepiness. Upper airway resistance increase during sleep and upper airway inspiratory muscle activity decrease especially during bursts of rapid eye movements in REM (Rapid Eye-Movements) sleep. In this study, the differences in respiratory functions, orofacial muscle tone changes, anxiety/depression, and quality of life of the patients according to the severity of Obstructive Sleep Apnea Syndrome will be investigated. The project is planned to be carried out with participants who applied to the Bitlis State Hospital Chest Diseases Clinic and were diagnosed with OSA by polysomnography and other diagnostic methods. Based on "the Apnea-Hypopnea Index OSA rating scoring for adult individuals", participants will be divided into three groups: mild, moderate, and severe OSA. Healthy participants will form the fourth group on the control level. The respiratory functions of the participants will be evaluated with spirometry and a standard application procedure will be used. With the MyotonPro device, the tone of the orofacial muscles (m. digastricus venter anterior and m. mylohyoideus, tongue and m. masseter, m. temporalis) will be evaluated and data transferred to the computer will be reported. In the muscle tonus evaluations, standardization in cervical positioning will be provided by a dual digital inclinometer. The Hospital Anxiety and Depression Scale (HAD) will be used to evaluate the anxiety/depression levels of the participants, and the Short Form-36 (SF-36), which is prescribed as the global gold standard, will be used in the assessment of the quality of life. MyotonPro reliability investigation will be done by two separate researchers. The researchers will perform measurements independently, at the baseline, and after 1 week. MyotonPro evaluations will be based on anatomical localization points. During the measurement, both researchers will use the standard positioning protocol at both evaluation times.
- Conditions
- Sleep Apnea Syndromes
- Being tested
- Evaluation
- Keywords
- Muscle Tone, Quality of Life, Depression, Respiration
- Medical subject headings
- Sleep Apnea Syndromes, Depression, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvaluationDiagnostic test
To examine the differences in respiratory functions, orofacial muscle tone changes, anxiety/ depression, and quality of life of the patients according to the severity of Obstructive Sleep Apnea Syndrome.
| Study group | Role | What they receive |
|---|---|---|
| Mild Severity OSAS | Mild sleep apnea: An Apnea-Hypopnea Index (AHI) of five to 14 events per hour. Receives: Diagnostic Test: Evaluation | |
| Moderate Severity OSAS | Moderate sleep apnea: An Apnea-Hypopnea Index (AHI) of 15 to 29 events per hour. Receives: Diagnostic Test: Evaluation | |
| High Severity OSAS | Severe sleep apnea: An Apnea-Hypopnea Index (AHI) of 30 or more events per hour Receives: Diagnostic Test: Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The muscle tone evaluation
MyotonPro device will be used for muscle tone evaluation.The device provides a controlled preload of 0.18 N for initial compression of the subcutaneous tissue and then release an additional 15-ms impulse of 0.40 N of mechanical force, which induces a damped or decaying natural oscillation of the tissue35. The calculation formula was as follows: S = amax. mprobe/Δl; amax - maximum amplitude of the oscillation in the acceleration signal; mprobe - mass (preload) of the probe of 0.18 N, Δl - amplitude of the displacement signal.
Measured: Day 1.
Secondary outcomes (1)
Evaluation of the anxiety and depression.
The Hospital Anxiety and Depression Scale will be used to evaluate the anxiety/depression levels of the participants. It consists of two subscales, one measuring anxiety, with seven items, and one measuring depression, with seven items, which are scored separately. Each item was answered by the patient on a 4-point (0 - 3) response category so the possible scores ranged from 0 to 21 for anxiety and 0 to 21 for depression. It takes 2 - 5 min to complete.
Measured: Day 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start21 Apr 2021
- Primary completion18 Sep 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea SyndromesStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bitlis Eren University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tülay Çevik Saldıran, Bitlis Eren University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04858399
- Sponsor's protocol ID
- BEU_2
- Acronym
- OSASMumecPRO
- Status last verified
- Jun 2022
- First submitted
- 21 Apr 2021
- Last updated
- 10 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of Orofacial Muscles With Myotonometer in Obstructive Sleep Apnea Syndrome and Investigation of the Risk of Exposure According to Disease Severity
- ClinicalTrials.gov ID
- NCT04858399
- Acronym / sponsor ID
- OSASMumecPRO / BEU_2
- Conditions
- Sleep Apnea Syndromes
- Keywords
- Muscle Tone, Quality of Life, Depression, Respiration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Bitlis Eren UniversityUniversity, hospital or other
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 18 Sep 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 26 Apr 2021 (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.
The study aim of the project is to investigate the differences in respiratory functions, orofacial muscle tone changes, anxiety/depression, and quality of life of the patients according to the severity of Obstructive Sleep Apnea Syndrome. At the same time, to examine the reliability of the use of the MyotonPro evaluation method, which takes place rapidly in the literature and clinic, in the orofacial pharyngeal muscle group.
Detailed description
Obstructive sleep apnea (OSA) syndrome is a common but often unrecognized disorder caused by pharyngeal collapse during sleep and characterized by frequent awakenings, disrupted sleep, and consequent excessive daytime sleepiness. Upper airway resistance increase during sleep and upper airway inspiratory muscle activity decrease especially during bursts of rapid eye movements in REM (Rapid Eye-Movements) sleep. In this study, the differences in respiratory functions, orofacial muscle tone changes, anxiety/depression, and quality of life of the patients according to the severity of Obstructive Sleep Apnea Syndrome will be investigated. The project is planned to be carried out with participants who applied to the Bitlis State Hospital Chest Diseases Clinic and were diagnosed with OSA by polysomnography and other diagnostic methods. Based on "the Apnea-Hypopnea Index OSA rating scoring for adult individuals", participants will be divided into three groups: mild, moderate, and severe OSA. Healthy participants will form the fourth group on the control level. The respiratory functions of the participants will be evaluated with spirometry and a standard application procedure will be used. With the MyotonPro device, the tone of the orofacial muscles (m. digastricus venter anterior and m. mylohyoideus, tongue and m. masseter, m. temporalis) will be evaluated and data transferred to the computer will be reported. In the muscle tonus evaluations, standardization in cervical positioning will be provided by a dual digital inclinometer. The Hospital Anxiety and Depression Scale (HAD) will be used to evaluate the anxiety/depression levels of the participants, and the Short Form-36 (SF-36), which is prescribed as the global gold standard, will be used in the assessment of the quality of life. MyotonPro reliability investigation will be done by two separate researchers. The researchers will perform measurements independently, at the baseline, and after 1 week. MyotonPro evaluations will be based on anatomical localization points. During the measurement, both researchers will use the standard positioning protocol at both evaluation times.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild Severity OSAS | – | Diagnostic Test: EvaluationMild sleep apnea: An Apnea-Hypopnea Index (AHI) of five to 14 events per hour. |
| Moderate Severity OSAS | – | Diagnostic Test: EvaluationModerate sleep apnea: An Apnea-Hypopnea Index (AHI) of 15 to 29 events per hour. |
| High Severity OSAS | – | Diagnostic Test: EvaluationSevere sleep apnea: An Apnea-Hypopnea Index (AHI) of 30 or more events per hour |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic in Bitlis.
Key inclusion criteria (3 listed)
- Age > 18 years old.
- Getting a diagnosis of OSAS with polysomnography.
- Agree to participate in the study.
Key exclusion criteria (7 listed)
- Having respiratory system disease (COPD, asthma, bronchiectasis, lung cancer, etc.).
- Sedative, hypnotic drug intake. Use of medical supplements such as diazepam.
- Hypothyroidism, acromegaly.
- Diagnosis of a psychiatric illness.
- Uncontrolled arrhythmia causing symptoms or hemodynamic impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EvaluationTo examine the differences in respiratory functions, orofacial muscle tone changes, anxiety/ depression, and quality of life of the patients according to the severity of Obstructive Sleep Apnea Syndrome. | Diagnostic test | High Severity OSAS, Mild Severity OSAS, Moderate Severity OSAS |
Primary outcome
The muscle tone evaluation
Time frame: Day 1.
MyotonPro device will be used for muscle tone evaluation.The device provides a controlled preload of 0.18 N for initial compression of the subcutaneous tissue and then release an additional 15-ms impulse of 0.40 N of mechanical force, which induces a damped or decaying natural oscillation of the tissue35. The calculation formula was as follows: S = amax. mprobe/Δl; amax - maximum amplitude of the oscillation in the acceleration signal; mprobe - mass (preload) of the probe of 0.18 N, Δl - amplitude of the displacement signal.
1 secondary outcome
Evaluation of the anxiety and depression.
Time frame: Day 1.
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 10 Jun 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Sleep Apnea Syndromes, run by Bitlis Eren 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 7 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 10 Jun 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?
The muscle tone evaluation (time frame: Day 1.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jun 2022.