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Comprehensive Management for the Treatment of Obstructive Sleep Apnea

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02482480
Enrollment
27
Registered
2015-06-26
Start date
2014-10-31
Completion date
2015-08-31
Last updated
2016-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SLEEP APNEA SYNDROME

Keywords

SLEEP, APNEA, EXERCISE

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.

Interventions

OTHERExercise

Walking in community Oropharyngeal exercises Diet recommendations Dietary recommendations Education

OTHERControl

Dietary and general recommendations

Sponsors

Hospital Clinic of Barcelona
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Apnea-hipopnea index (AHI)10 weeks

Secondary

MeasureTime frameDescription
OSA symtoms and quality of life10 weeksEpworth Sleepiness Score (ESE)-Quebec sleep questionnaire (QSQ)
Minutes per day of moderate-to-vigorous physical activity with Sensewear Armband10 weeks
Distance walking in the Six minute walking Test10 weeks
Anxiety and depression on the Hospital Anxiety and Depression questionnaire10 weeks

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026