N/A
N=40
Effects of Myofunctional Therapy With an Application in Severe Apnea/Hypopnea Sleep Obstructive Syndrome (MTASSAOS)
Obstructive Sleep Apnea-hypopnea Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT04438785 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Apnea Hypopnea Index (AHI) — 44.77; 47.36; 20.88; 35 events per hour — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- The intervention consists of myofunctional therapy (MT) using the AirwayGym app. (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Quironsalud
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Apnea Hypopnea Index (AHI) |
44.77; 47.36; 20.88; 35 | <0.001 sig |
| PRIMARY Evaluation of O2 Desaturation Index (ODI) |
36.31; 40.64; 19.4; 32.03 | 0.003 sig |
| SECONDARY Evaluation of Iowa Oral Performance Instrument (IOPI) Score |
44.1; 31.3 | 0.001 sig |
| SECONDARY Iowa Oral Performance Instrument Lip Strength |
27.89; 28.1; 44.11; 31.3 | 0.001 sig |
| SECONDARY Neck Circumference (cm) |
43.7; 43.7; 44.6; 43.5 | 0.92 |
| SECONDARY Waist Circumference (cm) |
109.2; 109.1; 108.84; 108.5 | 0.92 |
| SECONDARY Body Mass Index BMI |
28.9; 29.6; 28.8; 29.6 | 0.98 |
| SECONDARY Epworth Sleepiness Scale |
10.3; 9.3; 5.3; 9.6 | 0.001 sig |
| SECONDARY Pittsburgh Sleep Quality Index |
10.2; 8.8; 10.3; 9.78 | 0.22 |
Summary
• Background and study aims: Obstructive sleep apnea is a potentially serious sleep disorder. It causes breathing to stop and start repeatedly during sleep. There are several types of sleep apnea, the most common of which is obstructive sleep apnea. This type of apnea occurs when an individual's throat muscles intermittently relax and block the airway during sleep.
The classic treatment for this disease is based on weight loss, and exercise, and the use of a continuous positive airway pressure (CPAP) machine.
Myofunctional therapy (MT) is one of the newest treatments for sleep-disordered breathing. MT is based on daily exercises of the throat muscles in an attempt to strengthen them and facilitate opening of the airway.
Who can participate? Patients diagnosed with severe sleep apnea and aged between 18-75 years.
What does the study involve? Participants will be randomly allocated to either use of the "AirwayGym" smartphone app or no treatment for 3 months. The AirwayGym app provides instructions on how to perform exercises to strengthen the throat muscles and reminds participants to perform the exercises for 20 min per day. Participants will be assessed monthly at the clinic.
What are the possible benefits and risks of participating? Benefits: Curing sleep apnea syndrome. There are no significant risks for participants.
Where is the study run from? Hospital Quirónsalud Marbella (Spain) When is the study starting and how long is it expected to run for? October 2018 to January 2021 Who is funding the study? Investigator initiated and funded Who is the main contact? Dr. Carlos O'Connor Reina, [email protected]
Eligibility Criteria
Inclusion Criteria
- Age between 18-75 years
- Recently diagnosed with severe sleep apnea and do not have any previous experience or information with this pathology
- Consent signed
Exclusion Criteria
- BMI > 40 kg/m²
- Inability to fill up questionnaires
- Severe drug or alcohol abuse
- Hypnotic medication
- Not controlled coronary disease
- Decompensated Heart failure
- Stroke
- Systemic Disease associated with inflammatory diagnosed entity (arthritis, sarcoidosis, vasculitis, lupus…)
- Neuromuscular disease (like Duchenne)
- Craniofacial deformities.
- Active oncologic process.
- Any antecedents of MT treatment or other treatment for sleep apnea could affect study results of the study (surgery, Mandibular Advancement Device (MAD) or CPAP).
Once the patient accepted and signed consent and met inclusion criteria, they will be attended by Ent specialist to rule out:
- Severe upper airway obstruction (Complete nose obstruction, Tonsils grade IV/IV )
- Presence of tongue tie (Marchesani protocol) with limitation of tongue movements
- Antecedents or presence of temporomandibular joint disorders
Data sourced from ClinicalTrials.gov (NCT04438785). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.