Obstructive Sleep Apnea of AdultNCT04169984
Myofunctional Therapy in Patients With Mild-moderate Sleep Apnea
A study testing Myofunctional Therapy in people with Obstructive Sleep Apnea of Adult and Myofunctional Therapy, run by Hospital Universitario Ramon y Cajal at 1 site in Spain.
Trial summary
The main objective of this study is to compare the change in the apnea-hypopnea index (AHI) in patients with mild to moderate sleep apnea without daytime sleepiness after 12 months of myofunctional therapy exercises with respect to the placebo group (the placebo group will be instructed in simulation exercises that do… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obstructive Sleep Apnea of Adult, Myofunctional Therapy
- What is being tested?
- Myofunctional Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2020to Jun 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 and under 80 years old.
- Patients with apnea-hypopnea index from 5 to 29 assessed by a respiratory polygraphy.
- Absence of daytime sleepiness (Epworth sleepiness scale <12).
Who cannot join
- Refractory high blood pressure (blood pressure that is not controlled with three antihypertensive drugs, including a diuretic).
- Ictus, transient ischemic attack, neuromuscular diseases, acute coronary syndrome or hospitalization for worsening heart failure, in the previous 30 days.
- Professional drivers, profession of risk or respiratory failure.
- Previous surgical intervention for the treatment of sleep apnea (those patients who have refused treatment with CPAP or mandibular advancement devices after 1 month of not using them,could be included).
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario Ramón y Cajal, Pneumology Department
Madrid, 28034
Irene M Cano-Pumarega, PhD, MD, +34 686348243, irene.cano@yahoo.com
About this study
Official title: Myofunctional Therapy in Patients With Mild-moderate Sleep Apnea. Randomized Clinical Trial (MYTOSA).
The main objective of this study is to compare the change in the apnea-hypopnea index (AHI) in patients with mild to moderate sleep apnea without daytime sleepiness after 12 months of myofunctional therapy exercises with respect to the placebo group (the placebo group will be instructed in simulation exercises that do not alter the function or morphology of the upper airway)
Read the detailed description
Background: Alternative treatment therapies to positive upper airway pressure (CPAP) for obstructive sleep apnea syndrome (OSAS) have been developed in recent years. Myofunctional orofacial therapy (MFT) is one of these alternatives and consists of exercises that improve mobility and increase muscle strength of the orofacial structures that contribute to the etiopathogenesis of OSAS. To date, any study to treat sleep apnea patients under this therapy has been conducted in Spain. Moreover, its long-term effect has not been evaluated worldwide.
Main objective: to compare the reduction in the apnea-hypopnea index (AHI) in patients with mild to moderate sleep apnea without daytime sleepiness after 12 months of myofunctional therapy exercises with respect to the placebo group (the placebo group will be instructed in simulation exercises that do not alter the function or morphology of the upper airway) Methodology: A 12-month, randomized, parallel-group, clinical trial will be conducted. Patients with an AHI ≥ 5 events per hour assessed by a respiratory polygraphy (RP) will be randomized to a MFT treatment branch or to another placebo exercises branch. A speech therapist will instruct patients to perform the exercises in both groups for three months. At the end of this period, a RP will be performed on both groups and the same treatment that they were doing will be maintained at home. One year later, a new RP will be performed and changes in AHI, oximetry parameters and snoring will be compared in both groups, as well as sleepiness, quality of life and the degree of adherence to the treatment.
- Being tested
- Myofunctional Therapy, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myofunctional TherapyOther
Isometric, isokinetic and isotonic exercises for the upper airway muscles.
PlaceboOther
Exercises that do not alter the function or morphology of the upper airway.
| Study group | Role | What they receive |
|---|---|---|
| Myofunctional Therapy | Active comparator | This therapy consists of the practice of isotonic, isokinetic and isometric exercises that improve mobility and coordination and increase the muscular strength of the orofacial structures that contribute to the obstructive sleep apnea etiopathogenesis. Receives: Other: Myofunctional Therapy |
| Placebo | Placebo comparator | The placebo group will be instructed in simulation exercises that do not alter the function or morphology of the upper airway. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in AHI after myofunctional therapy
To compare the apnea-hypopnea index (AHI) in patients with mild to moderate sleep apnea without daytime sleepiness after 12 months of myofunctional therapy exercises with respect to the placebo group.
Measured: 3 months;12 months
Secondary outcomes (7)
Change in AIH after 1 year of myofunctional treatment compared to 3 months
To assess whether the change in IAH is maintained comparing 12 months of active home treatment with 3 months of active treatment with a speech pathologist.
Measured: 3 months;12 months
Change in snoring
To assess the change in snoring measured by the average intensity in decibels and the number of snoring events per hour.
Measured: 3 months;12 months
Change in oximeter parameters
To assess the change in oximeter parameters: percentage of recording time with oxygen saturation < 90% (CT90), oxygen desaturation index (ODI) and mean oxygen saturation
Measured: 3 months;12 months
Assessment of the degree of therapeutic adherence at 3,6 and 12 months
To assess the degree of therapeutic adherence to the exercises at 3, 6 and 12 months of treatment.
Measured: 3 months; 6 months;12 months
Assessment of generic health-related quality of life
To assess the generic health-related quality of life measured by Short Form-36 Health Survey (SF-36) questionnaire
Measured: 3 months;12 months
Assessment of sleep quality
To assess the sleep quality measured by Pittsburgh Quality of Sleep Index questionnaire
Measured: 3 months;12 months
Assessment of daytime sleepiness
To assess the change in daytime sleepiness measured by the Epworth sleepiness scale
Measured: 3 months;12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study startJun 2020 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea of AdultStudies 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
- Model description
- Two arms: active treatment group (myofunctional therapy) and placebo group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irene Cano-Pumarega, Hospital Universitario Ramon y Cajal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04169984
- Sponsor's protocol ID
- MYTOSA
- Status last verified
- Feb 2020
- First submitted
- 13 Nov 2019
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myofunctional Therapy in Patients With Mild-moderate Sleep Apnea. Randomized Clinical Trial (MYTOSA).
- ClinicalTrials.gov ID
- NCT04169984
- Acronym / sponsor ID
- MYTOSA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospital Universitario Ramon y CajalUniversity, hospital or other
- Study start
- Jun 2020 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 20 Nov 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 main objective of this study is to compare the change in the apnea-hypopnea index (AHI) in patients with mild to moderate sleep apnea without daytime sleepiness after 12 months of myofunctional therapy exercises with respect to the placebo group (the placebo group will be instructed in simulation exercises that do not alter the function or morphology of the upper airway)
Detailed description
Background: Alternative treatment therapies to positive upper airway pressure (CPAP) for obstructive sleep apnea syndrome (OSAS) have been developed in recent years. Myofunctional orofacial therapy (MFT) is one of these alternatives and consists of exercises that improve mobility and increase muscle strength of the orofacial structures that contribute to the etiopathogenesis of OSAS. To date, any study to treat sleep apnea patients under this therapy has been conducted in Spain. Moreover, its long-term effect has not been evaluated worldwide.
Main objective: to compare the reduction in the apnea-hypopnea index (AHI) in patients with mild to moderate sleep apnea without daytime sleepiness after 12 months of myofunctional therapy exercises with respect to the placebo group (the placebo group will be instructed in simulation exercises that do not alter the function or morphology of the upper airway) Methodology: A 12-month, randomized, parallel-group, clinical trial will be conducted. Patients with an AHI ≥ 5 events per hour assessed by a respiratory polygraphy (RP) will be randomized to a MFT treatment branch or to another placebo exercises branch. A speech therapist will instruct patients to perform the exercises in both groups for three months. At the end of this period, a RP will be performed on both groups and the same treatment that they were doing will be maintained at home. One year later, a new RP will be performed and changes in AHI, oximetry parameters and snoring will be compared in both groups, as well as sleepiness, quality of life and the degree of adherence to the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two arms: active treatment group (myofunctional therapy) and placebo group
| Arm | Type | Receives |
|---|---|---|
| Myofunctional Therapy | Active comparator | Other: Myofunctional TherapyThis therapy consists of the practice of isotonic, isokinetic and isometric exercises that improve mobility and coordination and increase the muscular strength of the orofacial structures that contribute to the obstructive sleep apnea etiopathogenesis. |
| Placebo | Placebo comparator | Other: PlaceboThe placebo group will be instructed in simulation exercises that do not alter the function or morphology of the upper airway. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients over 18 and under 80 years old.
- Patients with apnea-hypopnea index from 5 to 29 assessed by a respiratory polygraphy.
- Absence of daytime sleepiness (Epworth sleepiness scale <12).
Key exclusion criteria (4 listed)
- Refractory high blood pressure (blood pressure that is not controlled with three antihypertensive drugs, including a diuretic).
- Ictus, transient ischemic attack, neuromuscular diseases, acute coronary syndrome or hospitalization for worsening heart failure, in the previous 30 days.
- Professional drivers, profession of risk or respiratory failure.
- Previous surgical intervention for the treatment of sleep apnea (those patients who have refused treatment with CPAP or mandibular advancement devices after 1 month of not using them,could be included).
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 TherapyIsometric, isokinetic and isotonic exercises for the upper airway muscles. | Other | Myofunctional Therapy |
| PlaceboExercises that do not alter the function or morphology of the upper airway. | Other | Placebo |
Primary outcome
Change in AHI after myofunctional therapy
Time frame: 3 months;12 months
To compare the apnea-hypopnea index (AHI) in patients with mild to moderate sleep apnea without daytime sleepiness after 12 months of myofunctional therapy exercises with respect to the placebo group.
7 secondary outcomes
Change in AIH after 1 year of myofunctional treatment compared to 3 months
Time frame: 3 months;12 months
Change in snoring
Time frame: 3 months;12 months
Change in oximeter parameters
Time frame: 3 months;12 months
Assessment of the degree of therapeutic adherence at 3,6 and 12 months
Time frame: 3 months; 6 months;12 months
Assessment of generic health-related quality of life
Time frame: 3 months;12 months
Assessment of sleep quality
Time frame: 3 months;12 months
Assessment of daytime sleepiness
Time frame: 3 months;12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
- Individual participant dataSharing planned: No
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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.
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 in people with Obstructive Sleep Apnea of Adult and Myofunctional Therapy, run by Hospital Universitario Ramon y Cajal at 1 site in Spain.
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 4 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: status not confirmed, as of the sponsor's last update on 13 Feb 2020. 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 Spain. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Irene M Cano Pumarega, PhD, MD (+34 686348243, irene.cano@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in AHI after myofunctional therapy (time frame: 3 months;12 months). 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 13 Feb 2020.