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
1 other identifier
interventional
185
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 10, 2011
CompletedFirst Posted
Study publicly available on registry
June 29, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedResults Posted
Study results publicly available
February 19, 2015
CompletedFebruary 19, 2015
February 1, 2015
2.9 years
June 10, 2011
August 4, 2014
February 3, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Apnea-hypopnea Index (AHI) at One 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.
1 year
Secondary Outcomes (1)
Epworth Sleepiness Score (ESS)
1 year
Study Arms (2)
Lifestyle modification program
ACTIVE COMPARATORAt 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.
Simple lifestyle advice
PLACEBO COMPARATORSubjects 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Age 30 to 80 years
- AHI ≥ 5/hour
- Body mass index (BMI) greater than or equal to 25
- Written informed consent obtained
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Prince of Wales Hospital
Hong Kong, Hong Kong, China
Related Publications (1)
Ng SSS, Chan RSM, Woo J, Chan TO, Cheung BHK, Sea MMM, To KW, Chan KKP, Ngai J, Yip WH, Ko FWS, Hui DSC. A Randomized Controlled Study to Examine the Effect of a Lifestyle Modification Program in OSA. Chest. 2015 Nov;148(5):1193-1203. doi: 10.1378/chest.14-3016.
PMID: 25763792DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Susanna S Ng
- Organization
- ChineseUHK
Study Officials
- PRINCIPAL INVESTIGATOR
Susanna SS Ng, MBChB
Chinese Univesrity of Hong Kong
- STUDY DIRECTOR
David SC Hui, MD
Chinese University of Hong Kong
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Consultant
Study Record Dates
First Submitted
June 10, 2011
First Posted
June 29, 2011
Study Start
January 1, 2011
Primary Completion
December 1, 2013
Study Completion
March 1, 2014
Last Updated
February 19, 2015
Results First Posted
February 19, 2015
Record last verified: 2015-02