Trial Outcomes & Findings for Metabolic Impact of Intermittent CPAP (NCT NCT02824263)
NCT ID: NCT02824263
Last Updated: 2024-01-02
Results Overview
We will report the mean for all participants per group (CPAP vs. CPAP withdrawal).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
144 participants
Primary outcome timeframe
2 nights, <1 month apart. Data from each night was averaged to report a single value.
Results posted on
2024-01-02
Participant Flow
Patients with a history of obstructive sleep apnea (OSA) who were accustomed to CPAP use were enrolled from the Johns Hopkins Sleep Disorders Center.
144 participants signed a consent form. 15 subjects withdrew or were lost to follow up after consent, leaving 129 participants who were randomized to CPAP first (61) or CPAP withdrawal first (68) visits.
Participant milestones
| Measure |
CPAP First, Then OSA (CPAP Withdrawal)
This is a crossover study comparing effects of sleep apnea (CPAP withdrawal) vs CPAP.
Participants first underwent a CPAP study (continuation of established CPAP therapy) during 1 overnight visit in the sleep lab. After a washout of 1 to 4 weeks, they then had a OSA (CPAP withdrawal) study during 1 overnight visit in the sleep lab.
|
OSA First (CPAP Withdrawal), Then CPAP
This is a crossover study comparing effects of sleep apnea (CPAP withdrawal) vs CPAP.
Participants first underwent an OSA (CPAP withdrawal) study during 1 overnight visit in the sleep lab. After a washout of 1 to 4 weeks, they then had a CPAP (continuation of established CPAP therapy) study during 1 overnight visit in the sleep lab.
|
|---|---|---|
|
First Intervention (1 Night)
STARTED
|
61
|
68
|
|
First Intervention (1 Night)
COMPLETED
|
61
|
68
|
|
First Intervention (1 Night)
NOT COMPLETED
|
0
|
0
|
|
Washout (1 to 4 Weeks)
STARTED
|
61
|
68
|
|
Washout (1 to 4 Weeks)
COMPLETED
|
59
|
62
|
|
Washout (1 to 4 Weeks)
NOT COMPLETED
|
2
|
6
|
|
Second Intervention (1 Night)
STARTED
|
59
|
62
|
|
Second Intervention (1 Night)
COMPLETED
|
55
|
59
|
|
Second Intervention (1 Night)
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
CPAP First, Then OSA (CPAP Withdrawal)
This is a crossover study comparing effects of sleep apnea (CPAP withdrawal) vs CPAP.
Participants first underwent a CPAP study (continuation of established CPAP therapy) during 1 overnight visit in the sleep lab. After a washout of 1 to 4 weeks, they then had a OSA (CPAP withdrawal) study during 1 overnight visit in the sleep lab.
|
OSA First (CPAP Withdrawal), Then CPAP
This is a crossover study comparing effects of sleep apnea (CPAP withdrawal) vs CPAP.
Participants first underwent an OSA (CPAP withdrawal) study during 1 overnight visit in the sleep lab. After a washout of 1 to 4 weeks, they then had a CPAP (continuation of established CPAP therapy) study during 1 overnight visit in the sleep lab.
|
|---|---|---|
|
Washout (1 to 4 Weeks)
Withdrawal by Subject
|
2
|
6
|
|
Second Intervention (1 Night)
Withdrawal by Subject
|
4
|
3
|
Baseline Characteristics
Metabolic Impact of Intermittent CPAP
Baseline characteristics by cohort
| Measure |
CPAP First, Then OSA (CPAP Withdrawal)
n=61 Participants
This is a crossover study comparing effects of sleep apnea (CPAP withdrawal) vs CPAP.
Participants in this arm undergo a (1) CPAP study (continuation of established CPAP therapy), followed by a (2) CPAP withdrawal study.
|
OSA First (CPAP Withdrawal), Then CPAP
n=68 Participants
This is a crossover study comparing effects of sleep apnea (CPAP withdrawal) vs CPAP.
Participants in this arm undergo a (1) CPAP withdrawal study, followed by a (2) CPAP study (continuation of established CPAP therapy).
|
Total
n=129 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51 years
STANDARD_DEVIATION 12 • n=99 Participants
|
53 years
STANDARD_DEVIATION 12 • n=107 Participants
|
52 years
STANDARD_DEVIATION 12 • n=206 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
82 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
60 Participants
n=99 Participants
|
65 Participants
n=107 Participants
|
125 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · African American
|
21 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Caucasian
|
35 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
79 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Mixed
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Native American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
61 Participants
n=99 Participants
|
68 Participants
n=107 Participants
|
129 Participants
n=206 Participants
|
|
Diabetes status
No diabetes
|
25 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
|
Diabetes status
Prediabetes
|
17 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Diabetes status
Diabetes
|
19 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
History of hypertension
Hypertension
|
31 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
|
History of hypertension
No hypertension
|
30 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
67 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 2 nights, <1 month apart. Data from each night was averaged to report a single value.Population: missing values due to IV issues leading to incomplete collection.
We will report the mean for all participants per group (CPAP vs. CPAP withdrawal).
Outcome measures
| Measure |
CPAP
n=109 Participants
This is a crossover study comparing effects of sleep apnea (CPAP withdrawal) vs CPAP.
Participants are randomized to two arms. Either CPAP (continuation of established CPAP therapy), followed by a CPAP withdrawal
OR
CPAP withdrawal, followed by CPAP (continuation of established CPAP therapy)
|
CPAP Withdrawal
n=109 Participants
This is a crossover study comparing effects of sleep apnea (CPAP withdrawal) vs CPAP.
Participants are randomized to two arms. Either CPAP (continuation of established CPAP therapy), followed by a CPAP withdrawal
OR
CPAP withdrawal, followed by CPAP (continuation of established CPAP therapy)
|
|---|---|---|
|
Concentration of Plasma Free Fatty Acids (FFA, mmol/L)
|
0.47 mmol/L
Standard Deviation 14
|
0.51 mmol/L
Standard Deviation 0.12
|
PRIMARY outcome
Timeframe: 2 nights, <1 month apart. Data from each night was averaged to report a single value.Population: missing values due to IV issues leading to incomplete collection.
We will report the mean for all participants per group (CPAP vs. CPAP withdrawal).
Outcome measures
| Measure |
CPAP
n=109 Participants
This is a crossover study comparing effects of sleep apnea (CPAP withdrawal) vs CPAP.
Participants are randomized to two arms. Either CPAP (continuation of established CPAP therapy), followed by a CPAP withdrawal
OR
CPAP withdrawal, followed by CPAP (continuation of established CPAP therapy)
|
CPAP Withdrawal
n=109 Participants
This is a crossover study comparing effects of sleep apnea (CPAP withdrawal) vs CPAP.
Participants are randomized to two arms. Either CPAP (continuation of established CPAP therapy), followed by a CPAP withdrawal
OR
CPAP withdrawal, followed by CPAP (continuation of established CPAP therapy)
|
|---|---|---|
|
Concentration of Plasma Glucose (mg/dl)
|
100 mg/dl
Standard Deviation 18
|
101 mg/dl
Standard Deviation 21
|
PRIMARY outcome
Timeframe: 2 nights, <1 month apart. Data from each night was averaged to report a single value.Population: missing values due to IV issues leading to incomplete collection.
We will report the mean for all participants per group (CPAP vs. CPAP withdrawal).
Outcome measures
| Measure |
CPAP
n=110 Participants
This is a crossover study comparing effects of sleep apnea (CPAP withdrawal) vs CPAP.
Participants are randomized to two arms. Either CPAP (continuation of established CPAP therapy), followed by a CPAP withdrawal
OR
CPAP withdrawal, followed by CPAP (continuation of established CPAP therapy)
|
CPAP Withdrawal
n=110 Participants
This is a crossover study comparing effects of sleep apnea (CPAP withdrawal) vs CPAP.
Participants are randomized to two arms. Either CPAP (continuation of established CPAP therapy), followed by a CPAP withdrawal
OR
CPAP withdrawal, followed by CPAP (continuation of established CPAP therapy)
|
|---|---|---|
|
Concentration of Plasma Insulin (mcU/ml)
|
18 microunits/mL
Standard Deviation 8
|
18 microunits/mL
Standard Deviation 12
|
PRIMARY outcome
Timeframe: 2 nights, <1 month apart. Data from each night was averaged to report a single value.Population: Missing values due to IV issues leading to incomplete collection.
We will report the mean for all participants per group (CPAP vs. CPAP withdrawal).
Outcome measures
| Measure |
CPAP
n=108 Participants
This is a crossover study comparing effects of sleep apnea (CPAP withdrawal) vs CPAP.
Participants are randomized to two arms. Either CPAP (continuation of established CPAP therapy), followed by a CPAP withdrawal
OR
CPAP withdrawal, followed by CPAP (continuation of established CPAP therapy)
|
CPAP Withdrawal
n=108 Participants
This is a crossover study comparing effects of sleep apnea (CPAP withdrawal) vs CPAP.
Participants are randomized to two arms. Either CPAP (continuation of established CPAP therapy), followed by a CPAP withdrawal
OR
CPAP withdrawal, followed by CPAP (continuation of established CPAP therapy)
|
|---|---|---|
|
Concentration of Plasma Triglycerides (mg/dl)
|
127 mg/dl
Standard Deviation 65
|
128 mg/dl
Standard Deviation 74
|
SECONDARY outcome
Timeframe: 2 nights, <1 month apart. 5 OGTT values were averaged to a obtain a single value.Population: Missing values due to IV issues leading to incomplete collection.
We will report the mean of the area under the curve (AUC) during OGTT for all participants per group (CPAP vs. CPAP withdrawal).
Outcome measures
| Measure |
CPAP
n=105 Participants
This is a crossover study comparing effects of sleep apnea (CPAP withdrawal) vs CPAP.
Participants are randomized to two arms. Either CPAP (continuation of established CPAP therapy), followed by a CPAP withdrawal
OR
CPAP withdrawal, followed by CPAP (continuation of established CPAP therapy)
|
CPAP Withdrawal
n=105 Participants
This is a crossover study comparing effects of sleep apnea (CPAP withdrawal) vs CPAP.
Participants are randomized to two arms. Either CPAP (continuation of established CPAP therapy), followed by a CPAP withdrawal
OR
CPAP withdrawal, followed by CPAP (continuation of established CPAP therapy)
|
|---|---|---|
|
Oral Glucose Tolerance Test (OGTT)
|
19820 mg/dl*min
Standard Deviation 5818
|
19224 mg/dl*min
Standard Deviation 5324
|
SECONDARY outcome
Timeframe: 2 nights, <1 month apart, 1 measurement each visitPopulation: Some missing data due to technical problems during collection of EndoPAT data.
Measured in the morning using Itamar EndoPAT device. This will measure the ratio of blood flow after brachial artery occlusion to blood flow prior to brachial artery occlusion. Normal values range from approximately 1 to 3 with higher values being associated with better vascular function. We will report the mean for all participants per group (CPAP vs. CPAP withdrawal).
Outcome measures
| Measure |
CPAP
n=111 Participants
This is a crossover study comparing effects of sleep apnea (CPAP withdrawal) vs CPAP.
Participants are randomized to two arms. Either CPAP (continuation of established CPAP therapy), followed by a CPAP withdrawal
OR
CPAP withdrawal, followed by CPAP (continuation of established CPAP therapy)
|
CPAP Withdrawal
n=111 Participants
This is a crossover study comparing effects of sleep apnea (CPAP withdrawal) vs CPAP.
Participants are randomized to two arms. Either CPAP (continuation of established CPAP therapy), followed by a CPAP withdrawal
OR
CPAP withdrawal, followed by CPAP (continuation of established CPAP therapy)
|
|---|---|---|
|
Reactive Hyperemia Index (RHI)
|
2.21 Ratio
Standard Deviation 0.57
|
2.12 Ratio
Standard Deviation 0.65
|
SECONDARY outcome
Timeframe: 2 nights, <1 month apart, 1 measurement each visitPopulation: Some missing data due to technical problems during collection of EndoPAT data.
Measured in the morning using Itamar EndoPAT device. Augmentation index is measured once during each visit, and is expressed as a % increase in the pressure waveform during systole. We will report the mean for all participants per group (CPAP vs. CPAP withdrawal).
Outcome measures
| Measure |
CPAP
n=108 Participants
This is a crossover study comparing effects of sleep apnea (CPAP withdrawal) vs CPAP.
Participants are randomized to two arms. Either CPAP (continuation of established CPAP therapy), followed by a CPAP withdrawal
OR
CPAP withdrawal, followed by CPAP (continuation of established CPAP therapy)
|
CPAP Withdrawal
n=108 Participants
This is a crossover study comparing effects of sleep apnea (CPAP withdrawal) vs CPAP.
Participants are randomized to two arms. Either CPAP (continuation of established CPAP therapy), followed by a CPAP withdrawal
OR
CPAP withdrawal, followed by CPAP (continuation of established CPAP therapy)
|
|---|---|---|
|
Augmentation Index (AI)
|
3.3 percentage
Standard Deviation 16
|
6.3 percentage
Standard Deviation 16
|
Adverse Events
CPAP
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
CPAP Withdrawal
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CPAP
n=129 participants at risk
This is a crossover study comparing effects of sleep apnea (CPAP withdrawal) vs CPAP.
Participants are randomized to two arms. Either CPAP (continuation of established CPAP therapy), followed by a CPAP withdrawal
OR
CPAP withdrawal, followed by CPAP (continuation of established CPAP therapy)
|
CPAP Withdrawal
n=129 participants at risk
This is a crossover study comparing effects of sleep apnea (CPAP withdrawal) vs CPAP.
Participants are randomized to two arms. Either CPAP (continuation of established CPAP therapy), followed by a CPAP withdrawal
OR
CPAP withdrawal, followed by CPAP (continuation of established CPAP therapy)
|
|---|---|---|
|
Gastrointestinal disorders
Diverticulitis
|
0.78%
1/129 • Number of events 1 • Participants were assessed for adverse events beginning 3 days before each visit to screen for drowsiness related incidents. The longest duration for assessing adverse events was approximately 4 weeks (if visits 1 and 2 were 1 month apart).
The risks of the study are related to IV access, temporary discontinuation of CPAP for 3 nights resulting in possible drowsiness-related incidents
|
0.00%
0/129 • Participants were assessed for adverse events beginning 3 days before each visit to screen for drowsiness related incidents. The longest duration for assessing adverse events was approximately 4 weeks (if visits 1 and 2 were 1 month apart).
The risks of the study are related to IV access, temporary discontinuation of CPAP for 3 nights resulting in possible drowsiness-related incidents
|
|
Cardiac disorders
Blood pressure elevation
|
0.78%
1/129 • Number of events 1 • Participants were assessed for adverse events beginning 3 days before each visit to screen for drowsiness related incidents. The longest duration for assessing adverse events was approximately 4 weeks (if visits 1 and 2 were 1 month apart).
The risks of the study are related to IV access, temporary discontinuation of CPAP for 3 nights resulting in possible drowsiness-related incidents
|
0.00%
0/129 • Participants were assessed for adverse events beginning 3 days before each visit to screen for drowsiness related incidents. The longest duration for assessing adverse events was approximately 4 weeks (if visits 1 and 2 were 1 month apart).
The risks of the study are related to IV access, temporary discontinuation of CPAP for 3 nights resulting in possible drowsiness-related incidents
|
Additional Information
Jonathan Jun
Johns Hopkins University School of Medicine
Phone: 410-550-0115
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place