- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01384760
Lifestyle Modification Program to Treat Obstructive Sleep Apnea Patients (OSA)
A Randomized Controlled Study to Examine the Effect of Lifestyle Modification Program in Obstructive Sleep Apnea Patients
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Hong Kong
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Hong Kong, Hong Kong, China
- Prince of Wales Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Lifestyle modification program
At the 1st session, the dietitian carried out a complete behavioral assessment, with emphasis on patient's current eating and lifestyle patterns, specific eating-related behaviors, knowledge of risks associated with current eating patterns, and concerns and feelings about specific lifestyle changes. In the subsequent follow up visit, the dietitian reviewed the 7-day food diaries to ensure nutritional adequacy and treatment compliance, and also offered recommendations for controlling caloric intake. Patients were encouraged to see an exercise instructor who designed an individualized suitable exercise regime with cardiovascular and resistance exercises for the patients to perform at home. Subjects were encouraged to perform 30-minute aerobic exercise 2-3 times a week. |
During the first 4 months, subjects will come for a counseling session weekly and then monthly for the following months.
During each counseling session (15 to 20 minutes), the registered dietitian will review the seven-day food diaries and offer recommendations for controlling caloric intake.
A varied balanced diet with an emphasis on fruit and vegetables, and low-fat and low calorific products in appropriate portions were encouraged.
The registered dietitian will also review the daily activity log sheet to check the exercise adherence and progression set by exercise instructor.
Subjects will be encouraged to do 30 minutes aerobic exercise two to three times a week.
Other Names:
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Placebo Comparator: Simple lifestyle advice
Subjects in control group received simple lifestyle advice from a clinician at baseline and month 6.
This was a brief discussion about the general health risk associated with OSA and importance of balanced diet.
Subjects were encouraged to perform regular 30-minute exercise 2 to 3 times per week.
This was to resemble routine clinical practice.
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Subjects in control group will receive simple lifestyle advice from a clinician at baseline and month 6.
This will be a brief discussion about the general health risk associated with OSA and importance of balanced diet.
Subjects are encouraged to perform regular 30-minute exercise 2 to 3 times per week.
This is to resemble routine clinical practice.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Epworth Sleepiness Score (ESS)
Time Frame: 1 year
|
The Epworth Sleepiness Scale (ESS) is a questionnaire for assessing daytime sleepiness.
It was first described in 1991 as a simple, self-administered questionnaire.
The questionnaire is based on eight common situations in life.
Subjects are asked to rate on a scale of 0-3 about how likely they would fall asleep or doze off in these circumstances.
This gives a total score of 0 to 24 in each subject.The total score ranges from 0 to 24, with higher scores indicating higher sleepiness.
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1 year
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: David SC Hui, MD, Chinese University of Hong Kong
- Principal Investigator: Susanna SS Ng, MBChB, Chinese Univesrity of Hong Kong
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Resp/Ng/2011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Lifestyle modification
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