Comprehensive Management for the Treatment of Obstructive Sleep Apnea

March 17, 2016 updated by: Jose M. Montserrat, Hospital Clinic of Barcelona

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Catalunya
      • Barcelona, Catalunya, Spain, 08036
        • Hospital Clinic de Barcelona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Interventional group

Participants followed a 8-week intervention program with a total of 24 sessions (12 of those were supervised). The aim of the supervision was to increase the adherence to the treatment and to control the compliance of patients. General physical activity consisted in walking along previously standardized urban parks designed for the urban EPOC training project (Arbillaga-Etxarri et al, 2016). The duration of walking were 30 minutes. The physiotherapist supervised the accomplishment of other activities such as oropharyngeal exercises and diet control.

Oropharyngeal exercises:

  1. Expiratory muscle strength training (EMST):
  2. Masako Manoeuvre
  3. Shaker Head Lift:
  4. Facial exercise
Other: Exercise
Walking in community Oropharyngeal exercises Diet recommendations Dietary recommendations Education
SHAM_COMPARATOR: Control Group
Control group participants only received general recommendations regarding general physical activity, diet and sleep hygiene. After 8-weeks of control, they were re-evaluated with the same evaluation test used in the beginning of the study period. Recommendations for general physical activity were walking during 30 minutes at least 3 times a week maintaining the greatest possible pace. Also, control group patients received the same diet control document as intervention group and verbal advice for sleep hygiene. Approximately 1 month after enrolment, a follow-up phone call was completed were we also informed about the new re-evaluation data.
Other: Control
Dietary and general recommendations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Apnea-hipopnea index (AHI)
Time Frame: 10 weeks
10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OSA symtoms and quality of life
Time Frame: 10 weeks
Epworth Sleepiness Score (ESE)-Quebec sleep questionnaire (QSQ)
10 weeks
Minutes per day of moderate-to-vigorous physical activity with Sensewear Armband
Time Frame: 10 weeks
10 weeks
Distance walking in the Six minute walking Test
Time Frame: 10 weeks
10 weeks
Anxiety and depression on the Hospital Anxiety and Depression questionnaire
Time Frame: 10 weeks
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Investigators

  • Principal Investigator: Rodrigo Torres, MSc, University of Barcelona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (ACTUAL)

July 1, 2015

Study Completion (ACTUAL)

August 1, 2015

Study Registration Dates

First Submitted

March 25, 2015

First Submitted That Met QC Criteria

June 25, 2015

First Posted (ESTIMATE)

June 26, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

March 18, 2016

Last Update Submitted That Met QC Criteria

March 17, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SEPAR-ALAT-2014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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