Trial Outcomes & Findings for Study to Assess the Changes in Blood Clotting Factors and Blood Vessel Wall Function in Obstructive Sleep Apnea (NCT NCT00936481)
NCT ID: NCT00936481
Last Updated: 2013-10-25
Results Overview
Recruitment status
COMPLETED
Target enrollment
34 participants
Primary outcome timeframe
at the initial visit
Results posted on
2013-10-25
Participant Flow
Participants were recruited from the Vanderbilt sleep disorders clinics and from the community using emails and flyers from study start date in 2008- 2012
Once patients were enrolled in the trial and assigned to the groups, we were able to complete the protocols without having to exclude any participants.
Participant milestones
| Measure |
Healthy Controls
18 years or older with body mass index between 25-45
|
Obstructive Sleep Apnea Group
Age 18 years or older with body mass index between 25 and 45
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
17
|
|
Overall Study
COMPLETED
|
17
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Assess the Changes in Blood Clotting Factors and Blood Vessel Wall Function in Obstructive Sleep Apnea
Baseline characteristics by cohort
| Measure |
Healthy Controls
n=17 Participants
18 years or older with body mass index between 25-45
|
Obstructive Sleep Apnea Group
n=17 Participants
Age 18 years or older with body mass index between 25 and 45
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
37 years
STANDARD_DEVIATION 11 • n=5 Participants
|
49 years
STANDARD_DEVIATION 11 • n=7 Participants
|
43 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
17 participants
n=7 Participants
|
34 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at the initial visitOutcome measures
| Measure |
Healthy Controls
n=17 Participants
18 years or older with body mass index between 25-45
|
Obstructive Sleep Apnea Group
n=17 Participants
Age 18 years or older with body mass index between 25 and 45
|
|---|---|---|
|
Comparison of Levels of Mean PAI-1 Activity in Patients With Obstructive Sleep Apnea and Controls.
|
17.2 IU/ml
Standard Error 5.3
|
23.9 IU/ml
Standard Error 5.1
|
SECONDARY outcome
Timeframe: at initial visitOutcome measures
| Measure |
Healthy Controls
n=17 Participants
18 years or older with body mass index between 25-45
|
Obstructive Sleep Apnea Group
n=17 Participants
Age 18 years or older with body mass index between 25 and 45
|
|---|---|---|
|
Comparison of Endothelial (Blood Vessel) Wall Diameter in Patients With Obstructive Sleep Apnea Versus Controls.
|
0.43 mm
Standard Deviation 0.08
|
0.43 mm
Standard Deviation 0.06
|
Adverse Events
Healthy Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Obstructive Sleep Apnea Group
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
Kanika Bagai, MD, Assistant Professor
Vanderbilt Universit
Phone: 6153220283
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place