Obstructive Sleep ApneaNCT05043389
Impact of Myofuntional Therapy Program on Increasing Tongue Strength and Improving Sleep Apnea
A study testing myofunctional therapy program in people with Obstructive Sleep Apnea, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
Trial summary
This Research studies for compare muscle strength among OSA patients who treat with myofunctional therapy program in Rajavithi hospital Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- myofunctional therapy program
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jan 2021to 30 Sep 2022
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who diagnose with Obstructive sleep apnea 18-65 years
Who cannot join
- BMI>=35kg/m2
- alcoholic and smoke
- use sleeping pill
- craniofacial syndrome
- hypertrophic tonsils grade 3+, 4+
- severe comorbidity
- Use CAP
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Myofuntional Therapy Program on Increasing Tongue Strength and Improving Sleep Apnea: a Randomized Controlled Trail
This Research studies for compare muscle strength among OSA patients who treat with myofunctional therapy program in Rajavithi hospital
- Conditions
- Obstructive Sleep Apnea
- Being tested
- myofunctional therapy program
- Keywords
- myofunctional therapy, IOPI, Obstructive sleep apnea (OSA)
- 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.
myofunctional therapy programOther
Exercise oral cavity muscle
| Study group | Role | What they receive |
|---|---|---|
| Obstructive sleep apnea | Experimental | myofunctional therapy program Receives: Other: myofunctional therapy program |
| control | No intervention | standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare muscle strength
compare muscle strength before and after program by IOPI
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start1 Jan 2021
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Department of Medical Services Ministry of Public Health of Thailand
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Sasion Phaibunphunphiphat, MD, Principal investigator, Department of Medical Services Ministry of Public Health of Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05043389
- Sponsor's protocol ID
- 63238
- Status last verified
- Sep 2021
- First submitted
- 5 Sep 2021
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Myofuntional Therapy Program on Increasing Tongue Strength and Improving Sleep Apnea: a Randomized Controlled Trail
- ClinicalTrials.gov ID
- NCT05043389
- Acronym / sponsor ID
- 63238
- Conditions
- Obstructive Sleep Apnea
- Keywords
- myofunctional therapy, IOPI, Obstructive sleep apnea (OSA)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Department of Medical Services Ministry of Public Health of ThailandOther government
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 14 Sep 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.
This Research studies for compare muscle strength among OSA patients who treat with myofunctional therapy program in Rajavithi hospital
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obstructive sleep apnea | Experimental | Other: myofunctional therapy programmyofunctional therapy program |
| control | No intervention | –standard treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who diagnose with Obstructive sleep apnea 18-65 years
Key exclusion criteria (7 listed)
- BMI>=35kg/m2
- alcoholic and smoke
- use sleeping pill
- craniofacial syndrome
- hypertrophic tonsils grade 3+, 4+
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 |
|---|---|---|
| myofunctional therapy programExercise oral cavity muscle | Other | Obstructive sleep apnea |
Primary outcome
Compare muscle strength
Time frame: 1 year
compare muscle strength before and after program by IOPI
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 25 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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.
Sasion Phaibunphunphiphat, MD principal investigator
Department of Medical Services Ministry of Public Health of Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing myofunctional therapy program in people with Obstructive Sleep Apnea, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
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 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 25 Jan 2024. 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 Thailand. 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?
Compare muscle strength (time frame: 1 year). 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 25 Jan 2024.