Skip to main content
OpenTrials
Completed

NCT Number: NCT02482480

Comprehensive Management for the Treatment of Obstructive Sleep Apnea

Study objetives : The aim of this study is to assess the impact of a combined therapy treatment (physical exercise, oropharyngeal exercises and dietary recommendations) on symptoms and quality of life in patients with OSAS, as an alternative or addition to therapeutic treatment with nocturnal CPAP.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clinic de Barcelona

Barcelona, Catalonia, 08036, Spain

About this study

The obstructive sleep apnea syndrome (OSAS) is characterized by repetitive obstruction of the upper airway during sleep. OSAS is associated with a wide range of health consequences such as daytime sleepiness, cognitive impairment and metabolic and cardiovascular diseases. In Spain the prevalence of this disease is 3 to 6%, constituting a public health problem. The recommended first line treatment for OSAS is continuous positive pressure airway (CPAP).

Physical exercise has been shown to ameliorate the consequences of OSAS such as cardiovascular disease, glucose intolerance and fatigue. Scientific studies have shown that vigorous physical activity is associated with a decrease in the prevalence of OSAS, improved sleep efficiency and the Epworth Sleepiness Scale.

Moreover, recent evidence has shown that oropharyngeal exercises can be useful in the treatment of OSAS decreasing neck circumference, snoring, subjective sleepiness and AHI as well as improving the quality of life and saturation oxygen.

The 60-70% of patients with OSAS is overweight or obese showing that a high body mass index (BMI) is an independent risk factor for the occurrence of OSAS. Many studies have shown that weight loss is associated with significant reduction in AHI.

However, despite the scientific evidence to justify the inclusion of these modalities, there is no study that has analyzed the impact of performing together all these interventions. It is expected that the combination can produce a cumulative effect that impacts significantly on improving indicators of OSAS.

The investigators will include patients with a recent diagnosis of moderate or severe OSA. Patients will be randomized to interventional or control group.

Patients included in the study will be followed for almost three months and they will be examined at baseline and after time of follow-up or intervention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Moderate to severe Obstructive Sleep Apnea Hypopnea Syndrome (AHI > 15/h)

Exclusion criteria

  • BMI > 40
  • Concomitant heart disease, stroke or severe neuromuscular with medical judgment not doing exercise.
  • Musculoskeletal disorders that impede the realization of the exercises
  • Sleepiness affects your physical or occupational functioning.

Treatment and study plan

Exercise

Other

Walking in community Oropharyngeal exercises Diet recommendations Dietary recommendations Education

Control

Other

Dietary and general recommendations

Primary outcomes

  1. Apnea-hipopnea index (AHI)

    Time frame: 10 weeks

Secondary outcomes

  1. OSA symtoms and quality of life

    Time frame: 10 weeks

    Epworth Sleepiness Score (ESE)-Quebec sleep questionnaire (QSQ)

  2. Minutes per day of moderate-to-vigorous physical activity with Sensewear Armband

    Time frame: 10 weeks

  3. Distance walking in the Six minute walking Test

    Time frame: 10 weeks

  4. Anxiety and depression on the Hospital Anxiety and Depression questionnaire

    Time frame: 10 weeks

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Official study title

Effects of a Comprehensive Management Program for the Treatment of Obstructive Sleep Apnea Syndrome

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 26, 2015
Registry last updated
Mar 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.