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Comprehensive Management for the Treatment of Obstructive Sleep Apnea

Primary Purpose

SLEEP APNEA SYNDROME

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Exercise
Control
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for SLEEP APNEA SYNDROME focused on measuring SLEEP, APNEA, EXERCISE

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Clinic de Barcelona

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Interventional group

Control Group

Arm Description

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: Expiratory muscle strength training (EMST): Masako Manoeuvre Shaker Head Lift: Facial exercise

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.

Outcomes

Primary Outcome Measures

Apnea-hipopnea index (AHI)

Secondary Outcome Measures

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

Full Information

First Posted
March 25, 2015
Last Updated
March 17, 2016
Sponsor
Hospital Clinic of Barcelona
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1. Study Identification

Unique Protocol Identification Number
NCT02482480
Brief Title
Comprehensive Management for the Treatment of Obstructive Sleep Apnea
Official Title
Effects of a Comprehensive Management Program for the Treatment of Obstructive Sleep Apnea Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SLEEP APNEA SYNDROME
Keywords
SLEEP, APNEA, EXERCISE

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interventional group
Arm Type
Experimental
Arm Description
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: Expiratory muscle strength training (EMST): Masako Manoeuvre Shaker Head Lift: Facial exercise
Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Walking in community Oropharyngeal exercises Diet recommendations Dietary recommendations Education
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Dietary and general recommendations
Primary Outcome Measure Information:
Title
Apnea-hipopnea index (AHI)
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
OSA symtoms and quality of life
Description
Epworth Sleepiness Score (ESE)-Quebec sleep questionnaire (QSQ)
Time Frame
10 weeks
Title
Minutes per day of moderate-to-vigorous physical activity with Sensewear Armband
Time Frame
10 weeks
Title
Distance walking in the Six minute walking Test
Time Frame
10 weeks
Title
Anxiety and depression on the Hospital Anxiety and Depression questionnaire
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodrigo Torres, MSc
Organizational Affiliation
University of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08036
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Comprehensive Management for the Treatment of Obstructive Sleep Apnea

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