Lifestyle Modification Program to Treat Obstructive Sleep Apnea Patients

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.

Conditions

• Obstructive Sleep Apnea

Interventions

BEHAVIORAL

Simple lifestyle advice

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.

BEHAVIORAL

Lifestyle modification

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.

Sponsors & Collaborators

• Chinese University of Hong Kong

  lead OTHER

Principal Investigators

• Susanna SS Ng, MBChB · Chinese Univesrity of Hong Kong

• David SC Hui, MD · Chinese University of Hong Kong

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-01-31

Primary Completion

2013-12-31

Completion

2014-03-31

Countries

• China

Study Locations