Obstructive Sleep ApneaPhase 3NCT06681974
OROPHARYNGEAL MYOFUNCTIONAL THERAPY IN OBSTRUCTIVE SLEEP APNEA
A Phase 3 study testing EXPERIMENTAL: program of exercises that will be composed of 4 blocks in people with Obstructive Sleep Apnea, run by Instituto de Investigación Marqués de Valdecilla at 1 site in Spain.
Trial summary
Obstructive Sleep Apnea (OSA) is a prevalent nocturnal breathing disorder among the general population. Oropharyngeal myofunctional therapy (OMT) is an alternative conservative treatment used to improve OSA, associated health problems, and to improve the efficacy and tolerability of CPAP. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- EXPERIMENTAL: program of exercises that will be composed of 4 blocks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2023to 1 Dec 2024
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acceptance and signature of the informed consent
- Diagnosis of OSA with mild-moderate AHI without criteria for treatment with CPAP and/or other treatments (DAM).
- Patients who refused CPAP, were not candidates and/or refused DAM.
- Age > 18 years and < 70 years
Who cannot join
- Craniofacial malformations. Severe developmental delay. Intellectual disability.
- Diagnosis of neurodegenerative disease.
- Limited tongue mobility/presence of ankyloglossia as well as Temporo-Mandibular Joint pathology.
- Regular use of hypnotic medications
- Bulbar pathologies
- AHI of central origin above 50% of the total sleep time.
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- Obesity grade II or more.
- Severe cardiovascular, neuromuscular or pulmonary pathology or chronic domiciliary oxygen use. Hypoventilation-obesity syndrome.
- Refuse to participate in the clinical trial despite fulfilling the inclusion criteria and not presenting any exclusion criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital universitario Marques de Valdecilla
Santander
javier Uribarri, 942203389, javier.bolado@scsalud.es
About this study
Official title: RANDOMIZED CONTROLLED NON-INFERIORITY TRIAL TO ANALYZE THE EFFECTIVENESS OF OROPHARYNGEAL MYOFUNCTIONAL THERAPY IN MILD-MODERATE OBSTRUCTIVE SLEEP APNEA IN THE GENERAL POPULATION
Obstructive Sleep Apnea (OSA) is a prevalent nocturnal breathing disorder among the general population. Oropharyngeal myofunctional therapy (OMT) is an alternative conservative treatment used to improve OSA, associated health problems, and to improve the efficacy and tolerability of CPAP.
The objective is to determine the effect of OMT in the general population with mild-moderate OSA.
The overall study design will be a randomized controlled clinical trial with parallel groups. Both the control group and the intervention group will receive the same indications on the hygienic-dietary measures to be followed. The intervention group will also follow an exercise program based on OMT for 20 weeks. The effect on the apnea-hypopnea index and other variables will be determined by means of respiratory polygraphy before and after the intervention.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- CONTROL:Information form with hygienic-dietary measures or sleep hygiene guidelines is provided and explained., EXPERIMENTAL: program of exercises that will be composed of 4 blocks
- Keywords
- Oropharyngeal myofunctional therapy, Obstructive Sleep Apnea
- 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.
CONTROL:Information form with hygienic-dietary measures or sleep hygiene guidelines is provided and explained.Behavioural
- Establish a regular sleep schedule
- Do not stay in bed longer than our regular sleep schedule.
- Avoid naps during the day
- Do not perform exciting activities and/or activities that demand physical or mental energy in the 3 hours prior to going to bed.
- Avoid the use of mobile screens, as well as exposure to intense light in the 3 hours prior to going to bed.
- Follow a healthy bedtime routine
- Healthy lifestyle habits: avoid tobacco, alcohol and other toxic substances.
EXPERIMENTAL: program of exercises that will be composed of 4 blocksBiological
the first is the work of the soft palate (retropalatine level), the second is the work of the functionality of the tongue (retroglossus level), the third is the work of the position of the hyoid bone (hypopharyngeal level), and the fourth is work on anterior head tilt and craniocervical extension (anterior head posture).
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | indications on the hygienic-dietary measures Receives: Behavioral: CONTROL:Information form with hygienic-dietary measures or sleep hygiene guidelines is provided and explained. |
| experimental | Experimental | indications on the hygienic-dietary measures + an exercise program based on OMT for 20 weeks Receives: Biological: EXPERIMENTAL: program of exercises that will be composed of 4 blocks |
What is being measured
The primary outcome is the main question the study is designed to answer.
the effectiveness of Oropharyngeal myofunctional therapy in the treatment of Obstructive Sleep Apnea compared to conservative treatment measured by Respiratory Poligraphy
Measured: 12 months
Secondary outcomes (3)
the effectiveness of Oropharyngeal myofunctional therapy in the treatment of Obstructive Sleep Apnea on nocturnal and diurnal clinical variable measured by means of the Epworth Test
Measured: 12 months
the impact of Oropharyngeal myofunctional therapy in Obstructive Sleep Apnea treatment on quality of life in the general population diagnosed with mild-moderate OSA using the EuroQol-5D questionnaire.
Measured: 12 months
the degree of tolerance of Oropharyngeal myofunctional therapy in patients diagnosed with mild-moderate Obstructive Sleep Apnea using a Likert-type design Visual Analog Scale Rating and Pairwise Comparison Rating Scale (VAS-RRP).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start1 May 2023
- Primary completion1 May 2024
- Study completion1 Dec 2024 (estimated)
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Marqués de Valdecilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06681974
- Sponsor's protocol ID
- OMTOSA
- Status last verified
- Nov 2024
- First submitted
- 17 Jul 2024
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RANDOMIZED CONTROLLED NON-INFERIORITY TRIAL TO ANALYZE THE EFFECTIVENESS OF OROPHARYNGEAL MYOFUNCTIONAL THERAPY IN MILD-MODERATE OBSTRUCTIVE SLEEP APNEA IN THE GENERAL POPULATION
- ClinicalTrials.gov ID
- NCT06681974
- Acronym / sponsor ID
- OMTOSA
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Oropharyngeal myofunctional therapy, Obstructive Sleep Apnea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Instituto de Investigación Marqués de ValdecillaUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 12 Nov 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.
Obstructive Sleep Apnea (OSA) is a prevalent nocturnal breathing disorder among the general population. Oropharyngeal myofunctional therapy (OMT) is an alternative conservative treatment used to improve OSA, associated health problems, and to improve the efficacy and tolerability of CPAP.
The objective is to determine the effect of OMT in the general population with mild-moderate OSA.
The overall study design will be a randomized controlled clinical trial with parallel groups. Both the control group and the intervention group will receive the same indications on the hygienic-dietary measures to be followed. The intervention group will also follow an exercise program based on OMT for 20 weeks. The effect on the apnea-hypopnea index and other variables will be determined by means of respiratory polygraphy before and after the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Behavioral: CONTROL:Information form with hygienic-dietary measures or sleep hygiene guidelines is provided and explained.indications on the hygienic-dietary measures |
| experimental | Experimental | Biological: EXPERIMENTAL: program of exercises that will be composed of 4 blocksindications on the hygienic-dietary measures + an exercise program based on OMT for 20 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Acceptance and signature of the informed consent
- Diagnosis of OSA with mild-moderate AHI without criteria for treatment with CPAP and/or other treatments (DAM).
- Patients who refused CPAP, were not candidates and/or refused DAM.
- Age > 18 years and < 70 years
Key exclusion criteria (9 listed)
- Craniofacial malformations. Severe developmental delay. Intellectual disability.
- Diagnosis of neurodegenerative disease.
- Limited tongue mobility/presence of ankyloglossia as well as Temporo-Mandibular Joint pathology.
- Regular use of hypnotic medications
- Bulbar pathologies
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 |
|---|---|---|
| CONTROL:Information form with hygienic-dietary measures or sleep hygiene guidelines is provided and explained.* Establish a regular sleep schedule * Do not stay in bed longer than our regular sleep schedule. * Avoid naps during the day * Do not perform exciting activities and/or activities that demand physical or mental energy in the 3 hours prior to going to bed. * Avoid the use of mobile screens, as well as exposure to intense light in the 3 hours prior to going to bed. * Follow a healthy bedtime routine * Healthy lifestyle habits: avoid tobacco, alcohol and other toxic substances. | Behavioural | control group |
| EXPERIMENTAL: program of exercises that will be composed of 4 blocksthe first is the work of the soft palate (retropalatine level), the second is the work of the functionality of the tongue (retroglossus level), the third is the work of the position of the hyoid bone (hypopharyngeal level), and the fourth is work on anterior head tilt and craniocervical extension (anterior head posture). | Biological | experimental |
Primary outcome
the effectiveness of Oropharyngeal myofunctional therapy in the treatment of Obstructive Sleep Apnea compared to conservative treatment measured by Respiratory Poligraphy
Time frame: 12 months
3 secondary outcomes
the effectiveness of Oropharyngeal myofunctional therapy in the treatment of Obstructive Sleep Apnea on nocturnal and diurnal clinical variable measured by means of the Epworth Test
Time frame: 12 months
the impact of Oropharyngeal myofunctional therapy in Obstructive Sleep Apnea treatment on quality of life in the general population diagnosed with mild-moderate OSA using the EuroQol-5D questionnaire.
Time frame: 12 months
the degree of tolerance of Oropharyngeal myofunctional therapy in patients diagnosed with mild-moderate Obstructive Sleep Apnea using a Likert-type design Visual Analog Scale Rating and Pairwise Comparison Rating Scale (VAS-RRP).
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing EXPERIMENTAL: program of exercises that will be composed of 4 blocks in people with Obstructive Sleep Apnea, run by Instituto de Investigación Marqués de Valdecilla 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 4 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 14 Nov 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 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the effectiveness of Oropharyngeal myofunctional therapy in the treatment of Obstructive Sleep Apnea compared to conservative treatment measured by Respiratory Poligraphy (time frame: 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 14 Nov 2024; AzTrials last refreshed its copy on 7 Nov 2026.