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Effects of Myofunctional Therapy With an Application in Severe Apnea/Hypopnea Sleep Obstructive Syndrome (MTASSAOS)
NA trial testing The intervention consists of myofunctional therapy (MT) using the AirwayGym app. in Obstructive Sleep Apnea-hypopnea Syndrome in 40 participants. Completed in 30 September 2020.
| Lead sponsor | Quironsalud |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 1 March 2019 |
| Primary completion | 18 September 2020 |
| Estimated completion | 30 September 2020 |
| Sites | 2 locations across Spain |
Quironsalud
Adults 18 to 75, any sex, with Obstructive Sleep Apnea-hypopnea Syndrome. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Measurement of number of apneas or hypopneas recorded during the study per hour of sleep
| Group | Value | 95% CI |
|---|---|---|
| INTERVENTION (AirwayGym) GROUP | 44.77 | 33.84 – 55.69 |
| CONTROL GROUP | 47.36 | 38.59 – 56.13 |
| Group | Value | 95% CI |
|---|---|---|
| INTERVENTION (AirwayGym) GROUP | 20.88 | 14.02 – 27.74 |
| CONTROL GROUP | 35 | 31.2 – 38.7 |
The ODI is the number of times per hour of sleep that the blood oxygen level drops by a certain degree from baseline. Any respiratory event during sleep with a 3% drop in blood oxygen levels is counted towards the total. For example, a change from 95% to 92% would be an event that is counted toward the index's total.
| Group | Value | 95% CI |
|---|---|---|
| INTERVENTION (AirwayGym) GROUP | 36.31 | 27.19 – 43.43 |
| CONTROL GROUP | 40.64 | 29.46 – 51.81 |
| Group | Value | 95% CI |
|---|---|---|
| INTERVENTION (AirwayGym) GROUP | 19.4 | 12.9 – 25.98 |
| CONTROL GROUP | 32.03 | 24.14 – 39.91 |
The IOPI objectively measures maximum tongue strength in kilopascals and represents the tone of the genioglossus muscles.
| Group | Value | 95% CI |
|---|---|---|
| INTERVENTION (AirwayGym) GROUP | 44.1 | 39.5 – 48.8 |
| CONTROL GROUP | 31.3 | 26.6 – 35.9 |
The IOPI objectively measures maximum lip strength in kilopascals and represents the tone of the buccinator muscles.
| Group | Value | 95% CI |
|---|---|---|
| INTERVENTION (AirwayGym) GROUP | 27.89 | 24.16 – 32.47 |
| CONTROL GROUP | 28.1 | 23.7 – 32.5 |
| Group | Value | 95% CI |
|---|---|---|
| INTERVENTION (AirwayGym) GROUP | 44.11 | 39.5 – 48.8 |
| CONTROL GROUP | 31.3 | 26.6 – 35.9 |
Gives an idea if there is an anatomical change or reduction in fat in the upper airway muscles after intervention .
| Group | Value | 95% CI |
|---|---|---|
| INTERVENTION (AirwayGym) GROUP | 43.7 | 41.03 – 46.4 |
| CONTROL GROUP | 43.7 | 40.33 – 46.6 |
| Group | Value | 95% CI |
|---|---|---|
| INTERVENTION (AirwayGym) GROUP | 44.6 | 42.12 – 47.2 |
| CONTROL GROUP | 43.5 | 40.33 – 46.67 |
Gives an idea if there is an anatomical change or reduction of fat in the thorax muscles after intervention.
| Group | Value | 95% CI |
|---|---|---|
| INTERVENTION (AirwayGym) GROUP | 109.2 | 102.9 – 115.4 |
| CONTROL GROUP | 109.1 | 97.5 – 120.6 |
| Group | Value | 95% CI |
|---|---|---|
| INTERVENTION (AirwayGym) GROUP | 108.84 | 102.9 – 115.4 |
| CONTROL GROUP | 108.5 | 96.9 – 120.1 |
is a value derived from the mass (weight) and height of a person. The BMI is defined as the body mass in kilograms divided by the square of the body height in meters, and is expressed in units kg/m\^2 .
| Group | Value | 95% CI |
|---|---|---|
| INTERVENTION (AirwayGym) GROUP | 28.9 | 26.8 – 31.02 |
| CONTROL GROUP | 29.6 | 27.1 – 32.08 |
| Group | Value | 95% CI |
|---|---|---|
| INTERVENTION (AirwayGym) GROUP | 28.8 | 26.7 – 30.8 |
| CONTROL GROUP | 29.6 | 27.3 – 31.8 |
A scale (0-24), obtained by self-administered questionnaire, that rates an individual's probability of falling asleep on a scale of increasing probability from 0 to 3 for eight different situations that people experience in their daily lives.
| Group | Value | 95% CI |
|---|---|---|
| INTERVENTION (AirwayGym) GROUP | 10.3 | 8.71 – 12.24 |
| CONTROL GROUP | 9.3 | 6.6 – 12.11 |
| Group | Value | 95% CI |
|---|---|---|
| INTERVENTION (AirwayGym) GROUP | 5.3 | 3.45 – 7.2 |
| CONTROL GROUP | 9.6 | 6.8 – 12.3 |
A scale (0- 21) obtained by a self-report questionnaire that assesses sleep quality over a 1-month time interval. The questionnaire consists of a combination of Likerttype and open-ended questions (later converted to scaled scores using provided guidelines). Respondents are asked to indicate how frequently they have experienced certain sleep difficulties over the past month and to rate their overall sleep quality. Scores for each question range from 0 to 3, with higher scores indicating more acute sleep disturbances.A global score of 5 or more indicates poor sleep quality and that the higher
| Group | Value | 95% CI |
|---|---|---|
| INTERVENTION (AirwayGym) GROUP | 10.2 | 8.22 – 12.0 |
| CONTROL GROUP | 8.8 | 7.1 – 10.48 |
| Group | Value | 95% CI |
|---|---|---|
| INTERVENTION (AirwayGym) GROUP | 10.3 | 8.71 – 12.2 |
| CONTROL GROUP | 9.78 | 7.2 – 12.1 |
• 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, coconnor@us.es
2 peer-reviewed publications reference this trial (live from Europe PMC):
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