Comprehensive Management for the Treatment of Obstructive Sleep Apnea

SLEEP APNEA SYNDROME Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02482480
• Other study ID #: SEPAR-ALAT-2014
• Status: Completed
• Phase: N/A
• First received: March 25, 2015
• Last updated: March 17, 2016
• Start date: October 2014
• Est. completion date: August 2015

Study information

• Verified date: March 2016
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• SLEEP APNEA SYNDROME
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Other:
• Exercise
Walking in community Oropharyngeal exercises Diet recommendations Dietary recommendations Education
• Control
Dietary and general recommendations

Locations

Country	Name	City	State
Spain	Hospital Clinic de Barcelona	Barcelona	Catalunya

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea-hipopnea index (AHI)		10 weeks	Yes
Secondary	OSA symtoms and quality of life	Epworth Sleepiness Score (ESE)-Quebec sleep questionnaire (QSQ)	10 weeks	Yes
Secondary	Minutes per day of moderate-to-vigorous physical activity with Sensewear Armband		10 weeks	Yes
Secondary	Distance walking in the Six minute walking Test		10 weeks	Yes
Secondary	Anxiety and depression on the Hospital Anxiety and Depression questionnaire		10 weeks	Yes