Clinical trial NCT04169984: Myofunctional Therapy in Patients With Mild-moderate Sleep Apnea
Official title: Myofunctional Therapy in Patients With Mild-moderate Sleep Apnea. Randomized Clinical Trial (MYTOSA).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obstructive Sleep Apnea of Adult
Myofunctional Therapy
Lead sponsor: Hospital Universitario Ramon y Cajal
Sponsor class: OTHER
First posted: 2019-11-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two arms: active treatment group (myofunctional therapy) and placebo group
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Change in AHI after myofunctional therapy
timeFrame: 3 months;12 months
Secondary outcomes:
measure: Change in AIH after 1 year of myofunctional treatment compared to 3 months
timeFrame: 3 months;12 months
measure: Change in snoring
timeFrame: 3 months;12 months
measure: Change in oximeter parameters
timeFrame: 3 months;12 months
measure: Assessment of the degree of therapeutic adherence at 3,6 and 12 months
timeFrame: 3 months; 6 months;12 months
measure: Assessment of generic health-related quality of life
timeFrame: 3 months;12 months
measure: Assessment of sleep quality
timeFrame: 3 months;12 months
measure: Assessment of daytime sleepiness
timeFrame: 3 months;12 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal, Pneumology Department
Study officials:
References: