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Effect of Weight Loss and CPAP on OSA and Metabolic Profile Stratified by Craniofacial Phenotype

NCT03287973 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2021-02-15

No results posted yet for this study

Summary

Obstructive sleep apnea (OSA) is a common form of sleep-disordered breathing (SDB). Weight reduction has always been advocated in patients with OSA who are overweight and may lead to improvement in the severity of OSA. Previous study reported a randomized controlled trial of dietician-led lifestyle modification program (LMP) in 104 patients and found that LMP group had significantly more weight loss and reduced OSA severity, and the response was sustained after 8 months.

This study is aimed to compare the effect of weight loss or CPAP alone on subclinical inflammation, insulin resistance and blood pressure in patients with obesity and moderate-to-severe obstructive sleep apnea, stratified according to the degree of craniofacial restriction.

The study plans to recruit consecutive patients who have been referred to the Respiratory Clinic at the Prince of Wales Hospital with clinical suspicion of sleep-disordered breathing with specific study entry criteria including an age of 18 or more, body mass index (BMI) \>25 kg/m2, and moderate to severe OSA diagnosed by home sleep study. Patients having conditions that will affect the serum level of hsCRP will be excluded.

Conditions

Interventions

BEHAVIORAL

Lifestyle modification

A caloric reduction of 10-20% in daily energy intake from the patient's usual diet (i.e. a deficit ≥ 200 calories per day) will be set as the general initial goal, which will be adjusted subsequently based on changes in body weight with target body mass index (BMI) towards 23 kg/m2.

DEVICE

Continuous positive airway pressure (CPAP)

Patients randomized into the continuous positive airway pressure (CPAP) group in each arm will be interviewed by the physician on duty and invited to start autoCPAP treatment for 6 months. They will be offered a CPAP education package. Patients will then commence autoCPAP treatment for 6 months at home.

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

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

  • Susanna Ng, MBChB · Chinese University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-15
Primary Completion
2020-08-31
Completion
2020-08-31

Countries

  • Hong Kong

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03287973 on ClinicalTrials.gov