Trial Outcomes & Findings for Effects of CPAP on Visceral Fat Thickness (NCT NCT01828281)
NCT ID: NCT01828281
Last Updated: 2015-11-16
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
141 participants
Primary outcome timeframe
3 months
Results posted on
2015-11-16
Participant Flow
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.
51 subjects were excluded as 26 had AHI \<5 events/hour and 25 were not interested in continuing study.
Participant milestones
| Measure |
Therapeutic CPAP
The continuous positive airway pressure (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.
|
Control
subtherapeutic CPAP using 4 cm water
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
45
|
|
Overall Study
COMPLETED
|
44
|
45
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Therapeutic CPAP
The continuous positive airway pressure (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.
|
Control
subtherapeutic CPAP using 4 cm water
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Effects of CPAP on Visceral Fat Thickness
Baseline characteristics by cohort
| Measure |
Therapeutic CPAP
n=45 Participants
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.
|
Control
n=45 Participants
subtherapeutic CPAP using 4 cm water
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.3 years
STANDARD_DEVIATION 10.1 • n=99 Participants
|
48.7 years
STANDARD_DEVIATION 9.0 • n=107 Participants
|
49.5 years
STANDARD_DEVIATION 9.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
|
Neck circumference (cm)
|
40.7 cm
STANDARD_DEVIATION 11.3 • n=99 Participants
|
39.1 cm
STANDARD_DEVIATION 3.7 • n=107 Participants
|
39.9 cm
STANDARD_DEVIATION 7.5 • n=206 Participants
|
|
BMI (kg/m2)
|
28.2 kg/m2
STANDARD_DEVIATION 3.9 • n=99 Participants
|
28.2 kg/m2
STANDARD_DEVIATION 4.5 • n=107 Participants
|
28.2 kg/m2
STANDARD_DEVIATION 4.1 • n=206 Participants
|
|
Epworth Sleepiness Scale (ESS)
|
12.4 units on a scale
STANDARD_DEVIATION 5.9 • n=99 Participants
|
11.3 units on a scale
STANDARD_DEVIATION 4.7 • n=107 Participants
|
11.9 units on a scale
STANDARD_DEVIATION 5.1 • n=206 Participants
|
|
Systolic blood pressure
|
132.1 mmHg
STANDARD_DEVIATION 16.4 • n=99 Participants
|
129.4 mmHg
STANDARD_DEVIATION 21.6 • n=107 Participants
|
130.2 mmHg
STANDARD_DEVIATION 18.4 • n=206 Participants
|
|
Diastolic blood pressure
|
83.8 mmHg
STANDARD_DEVIATION 12.9 • n=99 Participants
|
83.9 mmHg
STANDARD_DEVIATION 14.1 • n=107 Participants
|
83.8 mmHg
STANDARD_DEVIATION 13.6 • n=206 Participants
|
|
Apnea hypopnea index (AHI) (event/hour)
|
30.6 event/hour
STANDARD_DEVIATION 21.4 • n=99 Participants
|
35.2 event/hour
STANDARD_DEVIATION 25.5 • n=107 Participants
|
33.2 event/hour
STANDARD_DEVIATION 22.4 • n=206 Participants
|
|
Mesenteric fat thickness
|
0.97 cm
STANDARD_DEVIATION 0.28 • n=99 Participants
|
0.98 cm
STANDARD_DEVIATION 0.26 • n=107 Participants
|
0.98 cm
STANDARD_DEVIATION 0.27 • n=206 Participants
|
|
Adiponectin
|
25.2 ug/ml
STANDARD_DEVIATION 25.9 • n=99 Participants
|
22.5 ug/ml
STANDARD_DEVIATION 23.8 • n=107 Participants
|
24.1 ug/ml
STANDARD_DEVIATION 23.9 • n=206 Participants
|
PRIMARY outcome
Timeframe: 3 monthsOutcome measures
| Measure |
Therapeutic CPAP
n=45 Participants
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.
|
Control
n=45 Participants
subtherapeutic CPAP using 4 cm water
CPAP: All subjects will undergo ultrasound examination of the abdomen the day after overnight PSG and then at 3 months after completion of therapeutic or subtherapeutic CPAP treatment of 4 cm water.
|
|---|---|---|
|
Mesenteric Fat Thickness
|
0.96 cm
Standard Deviation 0.16
|
0.94 cm
Standard Deviation 0.13
|
SECONDARY outcome
Timeframe: Baseline, 3 monthsMean changes in Adiponectin from baseline to 3 months.
Outcome measures
| Measure |
Therapeutic CPAP
n=45 Participants
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.
|
Control
n=45 Participants
subtherapeutic CPAP using 4 cm water
CPAP: All subjects will undergo ultrasound examination of the abdomen the day after overnight PSG and then at 3 months after completion of therapeutic or subtherapeutic CPAP treatment of 4 cm water.
|
|---|---|---|
|
Mean Changes in Adiponectin Over 3 Months
|
23.63 ug/ml
Standard Deviation 23.44
|
29.78 ug/ml
Standard Deviation 38.07
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsMean Hours of CPAP usage per day in those who continue to use CPAP during the three month period.
Outcome measures
| Measure |
Therapeutic CPAP
n=45 Participants
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.
|
Control
n=45 Participants
subtherapeutic CPAP using 4 cm water
CPAP: All subjects will undergo ultrasound examination of the abdomen the day after overnight PSG and then at 3 months after completion of therapeutic or subtherapeutic CPAP treatment of 4 cm water.
|
|---|---|---|
|
Mean Hours of CPAP Usage Per Day
|
4.18 hours
Standard Deviation 2.07
|
4.11 hours
Standard Deviation 1.99
|
Adverse Events
Therapeutic CPAP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place