Comprehensive Management for the Treatment of Obstructive Sleep Apnea

NCT ID: NCT02482480

Last Updated: 2016-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-08-31

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.

Conditions

SLEEP APNEA SYNDROME

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

Walking in community Oropharyngeal exercises Diet recommendations Dietary recommendations Education

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.

Group Type: SHAM_COMPARATOR

Control

Intervention Type: OTHER

Dietary and general recommendations

Interventions

Exercise

Walking in community Oropharyngeal exercises Diet recommendations Dietary recommendations Education

Intervention Type: OTHER

Control

Dietary and general recommendations

Intervention Type: OTHER

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Clinic of Barcelona

OTHER

Sponsor Role: lead

Responsible Party

Jose M. Montserrat

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rodrigo Torres, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Barcelona

Locations

Hospital Clinic de Barcelona

Barcelona, Catalonia, Spain

Countries

Spain

Other Identifiers

SEPAR-ALAT-2014

Identifier Type: -

Identifier Source: org_study_id