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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Placebo | Placebo Comparator | The placebo group will be instructed in simulation exercises that do not alter the function or morphology of the upper airway. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Myofunctional Therapy | Other | Isometric, isokinetic and isotonic exercises for the upper airway muscles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months;12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months;12 months |
| Change in snoring |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Irene M Cano Pumarega, PhD, MD | Contact | +34 686348243 | irene.cano@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Ramón y Cajal, Pneumology Department | Madrid | 28034 | Spain |
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| ID | Term |
|---|---|
| D020247 | Myofunctional Therapy |
| ID | Term |
|---|---|
| D012049 | Rehabilitation of Speech and Language Disorders |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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Two arms: active treatment group (myofunctional therapy) and placebo group
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| Placebo | Other | Exercises that do not alter the function or morphology of the upper airway. |
|
To assess the change in snoring measured by the average intensity in decibels and the number of snoring events per hour. |
| 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 | 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. | 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 | 3 months;12 months |
| Assessment of sleep quality | To assess the sleep quality measured by Pittsburgh Quality of Sleep Index questionnaire | 3 months;12 months |
| Assessment of daytime sleepiness | To assess the change in daytime sleepiness measured by the Epworth sleepiness scale | 3 months;12 months |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D003813 | Dentistry |