Obstructive Sleep ApneaNCT04201236
Oropharyngeal Exercises and Inspiratory Muscle Training in Obstructive Sleep Apnea
A study testing respiratory muscle strengthening exercise and oropharyngeal muscles strengthening exercise in people with Obstructive Sleep Apnea, run by Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The effects of orofarangeal exercises (OE) and inspiratory muscle training (IMT) on sleep quality, disease severity, and airway muscle tone have been investigated in several studies. IMT and OE exercise modalities for patients and practitioners have advantages and disadvantages. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- respiratory muscle strengthening exercise and oropharyngeal muscles strengthening exercise
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2019to 1 Oct 2019
- Phase
- Interventional
- 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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be diagnosed with mild, moderate and severe OSAS.
Who cannot join
- Patients with a history of stroke,
- neurological disease,
- severe obstructive nasal disease,
- and infection in the last month,
- BMI being 40 kg /m2 or more.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Trabzon Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital
Trabzon
About this study
Official title: Comparison of the Effectiveness of Inspiratory Muscle Training and Oropharyngeal Exercises in Patients With Obstructive Sleep Apnea Syndrome: a Randomized Controlled Trial
The effects of orofarangeal exercises (OE) and inspiratory muscle training (IMT) on sleep quality, disease severity, and airway muscle tone have been investigated in several studies. IMT and OE exercise modalities for patients and practitioners have advantages and disadvantages. It is recommended to compare exercise modalities in the studies. Whether OE or IMT exercise type is more effective on disease severity, sleep quality and snoring has not been investigated. The aim of this study was to compare the effectiveness of inspiratory muscle training and oropharyngeal exercises in patients with OSAS in terms of disease severity, snoring, daytime sleepiness, respiratory muscle strength and sleep quality.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- respiratory muscle strengthening exercise, oropharyngeal muscles strengthening exercise
- Keywords
- obstructive sleep apnea, oropharyngeal exercises, inspiratory muscle training, sleep quality
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
respiratory muscle strengthening exerciseOther
These exercises strengthen locally inspiratory muscles. IMT can be done with threshold loaded devices.
oropharyngeal muscles strengthening exerciseOther
These exercises strengthen locally oropharyngeal muscles. Oropharyngeal exercise can be done with some facial movements .
| Study group | Role | What they receive |
|---|---|---|
| Oropharyngeal exercises | Experimental | Oropharyngeal exercises include soft palate, tongue and facial muscle exercises as well as stomatognathic function exercises. Training sessions were held once a day, 5 days a week for 12 weeks under the supervision of a mirror. Receives: Other: oropharyngeal muscles strengthening exercise |
| Inspiratory muscle training | Experimental | The inspiratory muscle training group was administered for 12 weeks starting from 30% of maximal oral pressure, 7 days a week, 15 minutes twice a day. Patients came to the control once a week, mouth pressures were measured and training pressure was adjusted in 30% of the new value. Receives: Other: respiratory muscle strengthening exercise |
| Control | No intervention | This group was only monitorized without any rehabilitation intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polysomnography
Sleep efficiency, apnea-hypopnea index (AHI). Higher sleep efficiency and lower AHI values shows that patient have better status and lower disease severity
Measured: 2 day
Secondary outcomes (7)
Maximal inspiratory and expiratory muscle strength measurement with mouth pressure device
Respiratory muscle strength
Measured: 6 day
6 minute walk test
Exercise capacity
Measured: 2 day
Epworth Sleepiness Scale
minimum and maximum scores: 0-24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'
Measured: 2 day
Berlin Questionnaire
Snoring frequency (0-3) and severity (0-4). Higher scores show higher snoring frequency and severity
Measured: 2 day
Functional Outcomes of Sleep Questionnaire
Quality of life related with sleep. Minimum and maximum scores: 0-16. Higher scores show worse sleep related quality of life
Measured: 2 day
The Pittsburgh Sleep Quality Index
Sleep quality. Minimum and maximum scores: 0-21. Higher scores show worse sleep quality
Measured: 2 day
Fatigue Severity Scale
Fatigue severity. Minimum and maximum scores: 0-7. Scores higher than 4 shows high intensity fatigue perception
Measured: 2 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start1 Apr 2019
- Primary completion1 Oct 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NUREL ERTURK, Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital
- Investigators
- Adem Celik, MD, Study chair, Ahi Evren Thoracic and Cardiovascular Surgery Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04201236
- Sponsor's protocol ID
- 2019/11
- Status last verified
- Dec 2019
- First submitted
- 13 Dec 2019
- Last updated
- 18 Dec 2019
- 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 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Inspiratory Muscle Training and Oropharyngeal Exercises in Patients With Obstructive Sleep Apnea Syndrome: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04201236
- Acronym / sponsor ID
- 2019/11
- Conditions
- Obstructive Sleep Apnea
- Keywords
- obstructive sleep apnea, oropharyngeal exercises, inspiratory muscle training, sleep quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Ahi Evren Chest and Cardiovascular Surgery Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 17 Dec 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.
The effects of orofarangeal exercises (OE) and inspiratory muscle training (IMT) on sleep quality, disease severity, and airway muscle tone have been investigated in several studies. IMT and OE exercise modalities for patients and practitioners have advantages and disadvantages. It is recommended to compare exercise modalities in the studies. Whether OE or IMT exercise type is more effective on disease severity, sleep quality and snoring has not been investigated. The aim of this study was to compare the effectiveness of inspiratory muscle training and oropharyngeal exercises in patients with OSAS in terms of disease severity, snoring, daytime sleepiness, respiratory muscle strength and sleep quality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oropharyngeal exercises | Experimental | Other: oropharyngeal muscles strengthening exerciseOropharyngeal exercises include soft palate, tongue and facial muscle exercises as well as stomatognathic function exercises. Training sessions were held once a day, 5 days a week for 12 weeks under the supervision of a mirror. |
| Inspiratory muscle training | Experimental | Other: respiratory muscle strengthening exerciseThe inspiratory muscle training group was administered for 12 weeks starting from 30% of maximal oral pressure, 7 days a week, 15 minutes twice a day. Patients came to the control once a week, mouth pressures were measured and training pressure was adjusted in 30% of the new value. |
| Control | No intervention | –This group was only monitorized without any rehabilitation intervention. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- To be diagnosed with mild, moderate and severe OSAS.
Key exclusion criteria (5 listed)
- Patients with a history of stroke,
- neurological disease,
- severe obstructive nasal disease,
- and infection in the last month,
- BMI being 40 kg /m2 or more.
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 |
|---|---|---|
| respiratory muscle strengthening exerciseThese exercises strengthen locally inspiratory muscles. IMT can be done with threshold loaded devices. | Other | Inspiratory muscle training |
| oropharyngeal muscles strengthening exerciseThese exercises strengthen locally oropharyngeal muscles. Oropharyngeal exercise can be done with some facial movements . | Other | Oropharyngeal exercises |
Primary outcome
Polysomnography
Time frame: 2 day
Sleep efficiency, apnea-hypopnea index (AHI). Higher sleep efficiency and lower AHI values shows that patient have better status and lower disease severity
7 secondary outcomes
Maximal inspiratory and expiratory muscle strength measurement with mouth pressure device
Time frame: 6 day
6 minute walk test
Time frame: 2 day
Epworth Sleepiness Scale
Time frame: 2 day
Berlin Questionnaire
Time frame: 2 day
Functional Outcomes of Sleep Questionnaire
Time frame: 2 day
The Pittsburgh Sleep Quality Index
Time frame: 2 day
Fatigue Severity Scale
Time frame: 2 day
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 18 Dec 2019.
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
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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)
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Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
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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.
Adem Celik, MD study chair
Ahi Evren Thoracic and Cardiovascular Surgery Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing respiratory muscle strengthening exercise and oropharyngeal muscles strengthening exercise in people with Obstructive Sleep Apnea, run by Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital 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 1 inclusion and 5 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 18 Dec 2019. 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?
Polysomnography (time frame: 2 day). 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 18 Dec 2019.