Comprehensive Management for the Treatment of Obstructive Sleep Apnea

NCT02482480 | Completed DMC

• 1 other identifier: SEPAR-ALAT-2014
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

SLEEP APNEA SYNDROME

Keywords

SLEEP; APNEA; EXERCISE

Outcome Measures

Primary Outcomes (1)

• Apnea-hipopnea index (AHI)

  10 weeks

Secondary Outcomes (4)

• OSA symtoms and quality of life

  10 weeks

• Minutes per day of moderate-to-vigorous physical activity with Sensewear Armband

  10 weeks

• Distance walking in the Six minute walking Test

  10 weeks

• Anxiety and depression on the Hospital Anxiety and Depression questionnaire

  10 weeks

Study Arms (2)

Interventional group

EXPERIMENTAL

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

Other: Exercise

Control Group

SHAM COMPARATOR

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.

Other: Control

Interventions

Exercise OTHER

Walking in community Oropharyngeal exercises Diet recommendations Dietary recommendations Education

Interventional group

Control OTHER

Dietary and general recommendations

Control Group

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Moderate to severe Obstructive Sleep Apnea Hypopnea Syndrome (AHI \> 15/h)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clinic de Barcelona

Barcelona, Catalonia, 08036, Spain

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Apnea; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Rodrigo Torres, MSc

  University of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 25, 2015
• First Posted: June 26, 2015
• Study Start: October 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: August 1, 2015
• Last Updated: March 18, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)