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. 2020 Nov 3;2020(11):CD013449. doi: 10.1002/14651858.CD013449.pub2

NCT04169984.

Study name Myofunctional Therapy in Patients With Mild‐moderate Sleep Apnea.
Methods Parallel, RCT.
Participants Inclusion criteria: patients over 18 and under 80 years old, with AHI from 5 to 29 assessed by a respiratory polygraphy, and absence of daytime sleepiness (ESS lower than 12).
Exclusion criteria: refractory high blood pressure (blood pressure that is not controlled with three antihypertensive drugs, including a diuretic); ictus, transient ischaemic attack, neuromuscular diseases, acute coronary syndrome or hospitalisation 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 apnoea (those patients who have refused treatment with CPAP or mandibular advancement devices after 1 month of not using them, could be included).
Interventions Intervention: myofunctional therapy.
Comparator: sham comparator.
Outcomes Primary Outcome Measures:
  • Apnea Hypopnea Index.


Secondary Outcome Measures:
  • Change in snoring.

  • Change in oximeter parameters.

  • Degree of therapeutic adherence.

  • Quality of life (SF‐36).

  • Sleep quality (PQSI).

  • Daytime sleepiness (ESS).

Starting date Study Start Date: June 2020.
Estimated Study Completion Date: June 2022.
Contact information Irene M Cano Pumarega. Hospital Universitario Ramón y Cajal, Pneumology Department. Madrid. Spain.
Notes Information from ClinicalTrials.com.