SnoringNCT06186687
Rehabilitative Approaches: Myofunctional Therapy and Retropalatal Narrowing and Snoring
A study testing Myofunctional therapy exercise in people with Snoring and Pharyngeal Collapse, run by Universitas Padjadjaran at 1 site in Indonesia.
Trial summary
Sleep is an important activity and snoring is the most often reported complaint. Snoring is also very common in the general population. Moreover, snoring can negatively impact bed companions' quality of sleep, daytime sleepiness, strain of relationships, social embarrassment and disturb mental health that in the end… Read more about this study
- Who is it for?
- Ages 20 to 65 years, men only
- Conditions the study is for
- Snoring, Pharyngeal Collapse
- What is being tested?
- Myofunctional therapy exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Sep 2022to 28 Feb 2023
- 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 20 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- high risk of OSA (STOP-Bang questionnaire ≥ 3 and Berlin Questionnaire score positive in ≥ 2 category)
- Already diagnosed by an Ear, Nose and Throat specialist as having risk of obstructive sleep apnea based on the questionnaire and FN study that showed pharyngeal muscle collapse in the pharyngeal area (velopharyngeal area/retropalatal)
Who cannot join
- history of lung disease,
- craniofacial anatomy abnormalities,
- consuming drugs with sedative effects, alcohol, anti-depressants, or anti-anxiety groups in the last 3 months before
Trial locations and contacts
1 site in 1 country.
About this study
Sleep is an important activity and snoring is the most often reported complaint. Snoring is also very common in the general population. Moreover, snoring can negatively impact bed companions' quality of sleep, daytime sleepiness, strain of relationships, social embarrassment and disturb mental health that in the end will reduce quality of life. Anatomical risk factors are believed to be one of major contributors to upper airway constriction during sleep. Treatment for this condition include lifestyle modifications (such as quitting alcohol or losing weight), positional therapy, mandibular advancement devices, upper airway surgery, and nasal continuous positive airway pressure. Myofunctional therapy (MT) as an adjunctive or alternative therapy can lower Apnea-Hypopnea Index in obstructive sleep apnea patients with pharyngeal dilator muscle collapse. Although these may be beneficial, the impact of MT on retropalatal narrowing as one of the snoring causes needs to be better established. This study was done to find out the impact of MT in people with snoring who have a collapsed pharynx that is located by a Flexible nasolaryngoscopy.
Read the detailed description
Sleep is an important activity; it makes up one-third of a person's life, and in sleep medicine clinics, snoring is the most often reported complaint. Snoring is also very common in the general population. Studies indicate that women have a higher incidence of this condition above 65 years, increasing after menopause, while men experience it between 45 and 64 years of age. While snoring may be a predictor of the more serious condition of obstructive sleep apnea, primary snoring is common. Moreover, snoring can negatively impact bed companions' quality of sleep, daytime sleepiness, strain of relationships, social embarrassment and disturb mental health that in the end will reduce quality of life. Anatomical risk factors are believed to be one of major contributors to upper airway constriction during sleep. Pharyngeal narrowing can be facilitated by anatomic characteristics such as a large neck circumference, soft tissue, bone, or arteries. Flexible nasolaryngoscopy (FN) is an alternative diagnosis to direct viewing of the airway, from the nasal cavity to the larynx area. Aside from being easier to perform and more affordable, a complete examination of the airway can identify the location of the pharyngeal narrowing that causes obstruction more specifically. Treatment for this condition include lifestyle modifications (such as quitting alcohol or losing weight), positional therapy, mandibular advancement devices, upper airway surgery, and nasal continuous positive airway pressure are among the treatments for treating snoring. Myofunctional therapy (MT) as an adjunctive or alternative therapy can lower Apnea-Hypopnea Index in obstructive sleep apnea patients with pharyngeal dilator muscle collapse. The exercises are non-invasive, cost-effective, and have physiological characteristics. Improvement in upper airway obstruction is supported by improvements in upper airway muscle tone. Although these may be beneficial, the impact of MT on retropalatal narrowing as one of the snoring causes needs to be better established. This study was done to find out the impact of MT in people with snoring who have a collapsed pharynx that is located by a FN.
- Conditions
- Snoring, Pharyngeal Collapse
- Being tested
- Myofunctional therapy exercise
- Keywords
- Myofunctional therapy exercise, pharyngeal area collapse, snoring
- Medical subject headings
- Snoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myofunctional therapy exerciseBehavioural
Myofunctional therapy involves various exercises to train muscles in the soft palate, tongue, face, and pharynx. Vocal letters are used to train the palatopharyngeus, palatoglossus, uvula, tensor veli palatine, and levator veli palatine muscles. Tongue exercises involve sliding the tongue to the upper and side surfaces of the teeth, placing the tip in front of the palate, and pressing and sucking the tongue up to the palate. Face exercises involve inflating the cheeks, gargling, and sucking the cheeks to exercise the orbicularis oris muscle and the buccinator muscle. Icing stimulates the mouth, producing a cold, chilling, and numbing effect, causing reflexive contraction of the palate, tongue, and pharyngeal muscles.
| Study group | Role | What they receive |
|---|---|---|
| Myofunctional Therapy Exercise | Experimental | Seventeen patients whom already diagnosed by an Ear, Nose and Throat specialist as having risk of obstructive sleep apnea based on the questionnaire and FN study that showed pharyngeal muscle collapse in the pharyngeal area (velopharyngeal area/retropalatal), performed MT two times per day for 20 minutes every day for six weeks. Exercises were performed at home with monitoring by the exercise log book, submitting a clear video of each exercise, and being evaluated once a week by the doctor. Patient compliance was classified as good if the patient performed >75% of the exercises weekly. This study evaluated the velopharynx/retropalatal area (with FN), symptoms of daytime sleepiness with the Epworth Sleepiness Scale (ESS) questionnaire, and snoring intensity and frequency taken from the Berlin questionnaire that were filled out before and after undergoing training for 6 weeks. Receives: Behavioral: Myofunctional therapy exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Widening of retropalatal area
The retropalatal area was evaluated with flexible nasolaryngoscopy before and after 6 weeks of myofunctional therapy exercise.
Measured: 6 weeks
Symptoms of daytime sleepiness
Symptoms of daytime sleepiness was evaluated with Epworth Sleepiness Scale (ESS) score before and after 6 weeks of myofunctional therapy exercise. The minimum values of the socre is 0 and the maximum value is 24. The higher the ESS score, the higher their 'daytime sleepiness', which gives a worse outcome.
Measured: 6 weeks
Snoring intensity and frequency
Snoring intensity and frequency evaluation were taken from the Berlin questionnaire before and after 6 weeks of myofunctional therapy exercise.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study start1 Sep 2022
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SnoringStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Padjadjaran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vitriana Biben, Dr; MD, Principal investigator, Universitas Padjadjaran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06186687
- Sponsor's protocol ID
- IKFR-202312.01
- Status last verified
- Jan 2024
- First submitted
- 15 Dec 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitative Approaches: Myofunctional Therapy and Retropalatal Narrowing and Snoring
- ClinicalTrials.gov ID
- NCT06186687
- Acronym / sponsor ID
- IKFR-202312.01
- Conditions
- Snoring, Pharyngeal Collapse
- Keywords
- Myofunctional therapy exercise, pharyngeal area collapse, snoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Universitas PadjadjaranUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 2 Jan 2024 (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.
Sleep is an important activity and snoring is the most often reported complaint. Snoring is also very common in the general population. Moreover, snoring can negatively impact bed companions' quality of sleep, daytime sleepiness, strain of relationships, social embarrassment and disturb mental health that in the end will reduce quality of life. Anatomical risk factors are believed to be one of major contributors to upper airway constriction during sleep. Treatment for this condition include lifestyle modifications (such as quitting alcohol or losing weight), positional therapy, mandibular advancement devices, upper airway surgery, and nasal continuous positive airway pressure. Myofunctional therapy (MT) as an adjunctive or alternative therapy can lower Apnea-Hypopnea Index in obstructive sleep apnea patients with pharyngeal dilator muscle collapse. Although these may be beneficial, the impact of MT on retropalatal narrowing as one of the snoring causes needs to be better established. This study was done to find out the impact of MT in people with snoring who have a collapsed pharynx that is located by a Flexible nasolaryngoscopy.
Detailed description
Sleep is an important activity; it makes up one-third of a person's life, and in sleep medicine clinics, snoring is the most often reported complaint. Snoring is also very common in the general population. Studies indicate that women have a higher incidence of this condition above 65 years, increasing after menopause, while men experience it between 45 and 64 years of age. While snoring may be a predictor of the more serious condition of obstructive sleep apnea, primary snoring is common. Moreover, snoring can negatively impact bed companions' quality of sleep, daytime sleepiness, strain of relationships, social embarrassment and disturb mental health that in the end will reduce quality of life. Anatomical risk factors are believed to be one of major contributors to upper airway constriction during sleep. Pharyngeal narrowing can be facilitated by anatomic characteristics such as a large neck circumference, soft tissue, bone, or arteries. Flexible nasolaryngoscopy (FN) is an alternative diagnosis to direct viewing of the airway, from the nasal cavity to the larynx area. Aside from being easier to perform and more affordable, a complete examination of the airway can identify the location of the pharyngeal narrowing that causes obstruction more specifically. Treatment for this condition include lifestyle modifications (such as quitting alcohol or losing weight), positional therapy, mandibular advancement devices, upper airway surgery, and nasal continuous positive airway pressure are among the treatments for treating snoring. Myofunctional therapy (MT) as an adjunctive or alternative therapy can lower Apnea-Hypopnea Index in obstructive sleep apnea patients with pharyngeal dilator muscle collapse. The exercises are non-invasive, cost-effective, and have physiological characteristics. Improvement in upper airway obstruction is supported by improvements in upper airway muscle tone. Although these may be beneficial, the impact of MT on retropalatal narrowing as one of the snoring causes needs to be better established. This study was done to find out the impact of MT in people with snoring who have a collapsed pharynx that is located by a FN.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Myofunctional Therapy Exercise | Experimental | Behavioral: Myofunctional therapy exerciseSeventeen patients whom already diagnosed by an Ear, Nose and Throat specialist as having risk of obstructive sleep apnea based on the questionnaire and FN study that showed pharyngeal muscle collapse in the pharyngeal area (velopharyngeal area/retropalatal), performed MT two times per day for 20 minutes every day for six weeks. Exercises were performed at home with monitoring by the exercise log book, submitting a clear video of each exercise, and being evaluated once a week by the doctor. Patient compliance was classified as good if the patient performed >75% of the exercises weekly. This study evaluated the velopharynx/retropalatal area (with FN), symptoms of daytime sleepiness with the Epworth Sleepiness Scale (ESS) questionnaire, and snoring intensity and frequency taken from the Berlin questionnaire that were filled out before and after undergoing training for 6 weeks. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- high risk of OSA (STOP-Bang questionnaire ≥ 3 and Berlin Questionnaire score positive in ≥ 2 category)
- Already diagnosed by an Ear, Nose and Throat specialist as having risk of obstructive sleep apnea based on the questionnaire and FN study that showed pharyngeal muscle collapse in the pharyngeal area (velopharyngeal area/retropalatal)
Key exclusion criteria (3 listed)
- history of lung disease,
- craniofacial anatomy abnormalities,
- consuming drugs with sedative effects, alcohol, anti-depressants, or anti-anxiety groups in the last 3 months before
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 exerciseMyofunctional therapy involves various exercises to train muscles in the soft palate, tongue, face, and pharynx. Vocal letters are used to train the palatopharyngeus, palatoglossus, uvula, tensor veli palatine, and levator veli palatine muscles. Tongue exercises involve sliding the tongue to the upper and side surfaces of the teeth, placing the tip in front of the palate, and pressing and sucking the tongue up to the palate. Face exercises involve inflating the cheeks, gargling, and sucking the cheeks to exercise the orbicularis oris muscle and the buccinator muscle. Icing stimulates the mouth, producing a cold, chilling, and numbing effect, causing reflexive contraction of the palate, tongue, and pharyngeal muscles. | Behavioural | Myofunctional Therapy Exercise |
Primary outcome
Widening of retropalatal area
Time frame: 6 weeks
The retropalatal area was evaluated with flexible nasolaryngoscopy before and after 6 weeks of myofunctional therapy exercise.
Symptoms of daytime sleepiness
Time frame: 6 weeks
Symptoms of daytime sleepiness was evaluated with Epworth Sleepiness Scale (ESS) score before and after 6 weeks of myofunctional therapy exercise. The minimum values of the socre is 0 and the maximum value is 24. The higher the ESS score, the higher their 'daytime sleepiness', which gives a worse outcome.
Snoring intensity and frequency
Time frame: 6 weeks
Snoring intensity and frequency evaluation were taken from the Berlin questionnaire before and after 6 weeks of myofunctional therapy exercise.
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 5 Jan 2024.
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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.
Vitriana Biben, Dr; MD principal investigator
Universitas Padjadjaran
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 exercise in people with Snoring and Pharyngeal Collapse, run by Universitas Padjadjaran at 1 site in Indonesia.
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 2 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 5 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 Indonesia. 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?
Widening of retropalatal area (time frame: 6 weeks). 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?
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 5 Jan 2024.