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Clinical Trials/NCT01384760
NCT01384760
Completed
Not Applicable

A Randomized Controlled Study to Examine the Effect of Lifestyle Modification Program in Obstructive Sleep Apnea Patients

Chinese University of Hong Kong1 site in 1 country185 target enrollmentJanuary 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obstructive Sleep Apnea
Sponsor
Chinese University of Hong Kong
Enrollment
185
Locations
1
Primary Endpoint
Apnea-hypopnea Index (AHI) at One Year
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

Obstructive sleep apnea syndrome (OSAS) is a common form of sleep-disordered breathing (SDB) characterized by repetitive episodes of cessation of breathing during sleep due to upper airway collapse. It causes sleep fragmentation, disabling daytime sleepiness, impaired cognitive function and poor quality of life. In addition, OSAS is associated with non-fatal and fatal cardiovascular consequences including sudden death, in addition to an increased risk of road traffic accidents. Continuous positive airway pressure (CPAP) is considered as the first-line treatment for OSA. Oral appliance has been shown to reduce the severity of sleep disordered breathing and leads to symptomatic improvement especially in mild to moderate OSA. The compliance with CPAP is low particularly in mild or moderate OSA patients and it is not a curative treatment of OSA. It has to be used in every night on a regular basis. Weight reduction has always been advocated in patients with OSA who are overweight and may lead to improvement in the severity of OSA. The existing studies about weight loss are limited by small sample size, short duration (<6 months), focus on very low calorie diet program or surgically induced weight loss program only. However, none of them have applied lifestyle modification program (LMP) which emphasizes on long term lifestyle and behavior change. Therefore, the investigators plan to conduct a randomized controlled trial among Chinese OSA patients by comparing the efficacy of LMP against usual clinical lifestyle advice alone on the improvement of OSA symptoms.

Detailed Description

Obstructive sleep apnea syndrome (OSAS) is a common form of sleep-disordered breathing (SDB) characterized by repetitive episodes of cessation of breathing during sleep due to upper airway collapse. It causes sleep fragmentation, disabling daytime sleepiness, impaired cognitive function and poor quality of life. In addition, OSAS is associated with non-fatal and fatal cardiovascular consequences including sudden death, in addition to an increased risk of road traffic accidents. OSAS is equally common among the middle-aged male Caucasian and Hong Kong (HK) Chinese populations with prevalence rates of at least 4%. The prevalence and severity of OSAS tend to increase through adult life, peaking in the late fifties to mid sixties, after which it fails to increase or decrease. Another group of investigators reported high prevalence rates of SDB in a group aged 65-95 years of 70% for men and 56% for women, at least double those reported for middle-aged cohorts. Risk factors for OSA include obesity, increasing age, being male, abnormal craniofacial morphology, nasal obstruction, genetic factors. OSA is associated with several cardiovascular consequences and social consequences e.g. motor vehicle accidents, impaired cognitive performance, depression. Various epidemiologic studies have shown an association between OSA and hypertension. In cross-sectional study, OSA was associated with increased prevalence of self-reported heart failure and stroke. OSA has been shown to be independently associated with coronary artery disease after adjustment for traditionally considered risk factors. Continuous positive airway pressure (CPAP) is considered as the first-line treatment for OSA. Oral appliance has been shown to reduce the severity of sleep disordered breathing and leads to symptomatic improvement especially in mild to moderate OSA. The compliance with CPAP is low particularly in mild or moderate OSA patients and it is not a curative treatment of OSA. It has to be used in every night on a regular basis. Weight reduction has always been advocated in patients with OSA who are overweight and may lead to improvement in the severity of OSA. A population-based longitudinal study showed that a 10% weight loss predicted a 26% decrease in apnoea-hypopnoea index (AHI), a count of the number of upper airway obstructions per hour of sleep. The existing studies about weight loss are limited by small sample size, short duration (\<6 months), focus on very low calorie diet program or surgically induced weight loss program only. However, none of them have applied lifestyle modification program (LMP) which emphasizes on long term lifestyle and behavior change. Therefore, the investigators plan to conduct a randomized controlled trial among Chinese OSA patients by comparing the efficacy of LMP against usual clinical lifestyle advice alone on the improvement of OSA symptoms. Aim of the study: The investigators aim to test the hypothesis that LMP is superior to lifestyle advice alone in the management of Chinese patients with OSA. The primary outcome measure is the change of AHI. The secondary outcome measures are changes in quality of life, symptoms related to OSA, glucose, and insulin metabolism parameters. Hypothesis: The investigators hypothesize that more OSA patients in a low glycemic index dietary intervention program than patients receiving simple lifestyle advice alone will have reduction in AHI.

Registry
clinicaltrials.gov
Start Date
January 2011
End Date
March 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Susanna SS Ng

Associate Consultant

Chinese University of Hong Kong

Eligibility Criteria

Inclusion Criteria

  • Age 30 to 80 years
  • AHI ≥ 5/hour
  • Body mass index (BMI) greater than or equal to 25
  • Written informed consent obtained
  • Exclusion criteria:
  • Presence of sleepiness which may constitute risk to self or others
  • Chronic kidney, thyroid, or liver disease
  • Coexistence of sleep disorders other than OSA
  • History of previous surgery to upper airway (except those for nasal problems)
  • Previous surgical or current medical treatment for OSA Pregnant women

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Apnea-hypopnea Index (AHI) at One Year

Time Frame: 1 year

AHI is a count of the number of upper airway obstruction per hour of sleep. The index will be derived from the overnight home sleep study.

Secondary Outcomes

  • Epworth Sleepiness Score (ESS)(1 year)

Study Sites (1)

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