Obstructive Sleep Apnea
Conditions
Brief summary
We hypothesize that patients with untreated OSAS will have more visceral fat, fatty liver and increased carotid artery thickness whereas treatment with CPAP may reduce the mesenteric and liver fat, plasma lipids, carotid artery thickness.
Detailed description
This proposed randomized control trial (RCT) will compare the effects of therapeutic CPAP versus subtherapeutic CPAP in patients newly diagnosed with OSA with reference to visceral fat especially mesenteric fat thickness, liver fat, carotid artery intima media thickness (IMT), lateral pharyngeal wall (LPW) thickness, plasma lipids and adipokines over a treatment period of 3 months. The results of this study will advance our understanding of the relative role of OSA and obesity in the pathogenesis of metabolic syndrome (MetS) and whether CPAP therapy can improve these metabolic dysregulation.
Interventions
DEVICECPAP
All subjects will undergo ultrasound examination of the abdomen the day after overnight polysomnography (PSG) and then at 3 months after completion of therapeutic or subtherapeutic CPAP treatment of 4 cm water.
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* symptomatic patients with OSA of apnea hypopnea index (AHI) \>= 5/hr
Exclusion criteria
* Recent or past history of myocardial infarction/stroke/heart failure, unstable angina, underlying malignancy, * patients with clinical features of any active infection * those who require urgent CPAP treatment because of associated respiratory failure or to prevent job loss through excessive daytime sleepiness (eg professional drivers, those handling dangerous machinery) * moderate to severe valvular heart disease, cardiomyopathy, and previous diagnosis of OSA and/or previous use of CPAP therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mesenteric Fat Thickness | 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Changes in Adiponectin Over 3 Months | Baseline, 3 months | Mean changes in Adiponectin from baseline to 3 months. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mean Hours of CPAP Usage Per Day | 3 months | Mean Hours of CPAP usage per day in those who continue to use CPAP during the three month period. |
Countries
China
Participant flow
Recruitment details
Subjects were recruited from patients referred by general practitioners to the respiratory clinics with clinical suspicion of sleep-disordered breathing over the period 17 Feb 2012 to 30 Oct 2013. Overnight polysomnography (PSG) were performed as inpatient at the hospital.
Pre-assignment details
51 subjects were excluded as 26 had AHI \<5 events/hour and 25 were not interested in continuing study.
Participants by arm
| Arm | Count |
|---|---|
| Therapeutic CPAP The CPAP level for each patient in the arm was set at the minimum pressure needed to abolish snoring, obstructive respiratory events and airflow limitation for 95% of the night, as determined by the overnight CPAP titration study. | 45 |
| Control subtherapeutic CPAP using 4 cm water | 45 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Control | Therapeutic CPAP |
|---|---|---|---|
| Adiponectin | 24.1 ug/ml STANDARD_DEVIATION 23.9 | 22.5 ug/ml STANDARD_DEVIATION 23.8 | 25.2 ug/ml STANDARD_DEVIATION 25.9 |
| Age, Continuous | 49.5 years STANDARD_DEVIATION 9.5 | 48.7 years STANDARD_DEVIATION 9 | 50.3 years STANDARD_DEVIATION 10.1 |
| Apnea hypopnea index (AHI) (event/hour) | 33.2 event/hour STANDARD_DEVIATION 22.4 | 35.2 event/hour STANDARD_DEVIATION 25.5 | 30.6 event/hour STANDARD_DEVIATION 21.4 |
| BMI (kg/m2) | 28.2 kg/m2 STANDARD_DEVIATION 4.1 | 28.2 kg/m2 STANDARD_DEVIATION 4.5 | 28.2 kg/m2 STANDARD_DEVIATION 3.9 |
| Diastolic blood pressure | 83.8 mmHg STANDARD_DEVIATION 13.6 | 83.9 mmHg STANDARD_DEVIATION 14.1 | 83.8 mmHg STANDARD_DEVIATION 12.9 |
| Epworth Sleepiness Scale (ESS) | 11.9 units on a scale STANDARD_DEVIATION 5.1 | 11.3 units on a scale STANDARD_DEVIATION 4.7 | 12.4 units on a scale STANDARD_DEVIATION 5.9 |
| Mesenteric fat thickness | 0.98 cm STANDARD_DEVIATION 0.27 | 0.98 cm STANDARD_DEVIATION 0.26 | 0.97 cm STANDARD_DEVIATION 0.28 |
| Neck circumference (cm) | 39.9 cm STANDARD_DEVIATION 7.5 | 39.1 cm STANDARD_DEVIATION 3.7 | 40.7 cm STANDARD_DEVIATION 11.3 |
| Sex: Female, Male Female | 27 Participants | 14 Participants | 13 Participants |
| Sex: Female, Male Male | 63 Participants | 31 Participants | 32 Participants |
| Systolic blood pressure | 130.2 mmHg STANDARD_DEVIATION 18.4 | 129.4 mmHg STANDARD_DEVIATION 21.6 | 132.1 mmHg STANDARD_DEVIATION 16.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 45 | 0 / 45 |
| serious Total, serious adverse events | 0 / 45 | 0 / 45 |
Outcome results
Primary
Mesenteric Fat Thickness
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Therapeutic CPAP | Mesenteric Fat Thickness | 0.96 cm | Standard Deviation 0.16 |
| Control | Mesenteric Fat Thickness | 0.94 cm | Standard Deviation 0.13 |
Secondary
Mean Changes in Adiponectin Over 3 Months
Mean changes in Adiponectin from baseline to 3 months.
Time frame: Baseline, 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Therapeutic CPAP | Mean Changes in Adiponectin Over 3 Months | 23.63 ug/ml | Standard Deviation 23.44 |
| Control | Mean Changes in Adiponectin Over 3 Months | 29.78 ug/ml | Standard Deviation 38.07 |
Other Pre-specified
Mean Hours of CPAP Usage Per Day
Mean Hours of CPAP usage per day in those who continue to use CPAP during the three month period.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Therapeutic CPAP | Mean Hours of CPAP Usage Per Day | 4.18 hours | Standard Deviation 2.07 |
| Control | Mean Hours of CPAP Usage Per Day | 4.11 hours | Standard Deviation 1.99 |