Clinical trial NCT02482480: 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
Overall status: COMPLETED
Phase: NA
Conditions: SLEEP APNEA SYNDROME
Keywords: SLEEP
APNEA
EXERCISE
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2015-06-26
Enrollment: 27
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Apnea-hipopnea index (AHI)
timeFrame: 10 weeks
Secondary outcomes:
measure: OSA symtoms and quality of life
timeFrame: 10 weeks
measure: Minutes per day of moderate-to-vigorous physical activity with Sensewear Armband
timeFrame: 10 weeks
measure: Distance walking in the Six minute walking Test
timeFrame: 10 weeks
measure: Anxiety and depression on the Hospital Anxiety and Depression questionnaire
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
state: Catalunya
Study officials:
affiliation: University of Barcelona
name: Rodrigo Torres, MSc
role: PRINCIPAL_INVESTIGATOR
References: