N/A
N=104
Lifestyle Modification Program to Treat Obstructive Sleep Apnea Patients
Obstructive Sleep Apnea
Bottom Line
View on ClinicalTrials.gov: NCT01384760 ↗Enrolled (actual)
104
Serious AEs
0.0%
Results posted
Feb 2015
Primary outcome: Primary: Apnea-hypopnea Index (AHI) at One Year — 35.3; 39.6 events per hour
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lifestyle modification (Behavioral); Simple lifestyle advice (Behavioral)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Chinese University of Hong Kong
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Apnea-hypopnea Index (AHI) at One Year |
35.3; 39.6 | — |
| SECONDARY Epworth Sleepiness Score (ESS) |
8.9; 9.2 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01384760). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.