Trial Outcomes & Findings for Improving Obstructive Sleep Apnea Management Via Wireless Telemonitoring (NCT NCT00682838)
NCT ID: NCT00682838
Last Updated: 2016-09-01
Results Overview
Nightly CPAP adherence hours per night measured over the three-months period
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
280 participants
Primary outcome timeframe
3 mos
Results posted on
2016-09-01
Participant Flow
Participant milestones
| Measure |
Self-Management (SM)
Active Intervention
Self-management: Self-management Educational component focused on sleep apnea and CPAP from a self-management perspective
|
Telemonitored Care (TC)
Active Comparator
Telemonitored care: Telemonitored care Consists of CPAP therapist actively monitoring care at a distance, and acting on that data per a set protocol
|
SM + TC
1+2
Self-management: Self-management
Telemonitored care: Telemonitored care
Combination of both SM + TC intervention
|
Usual Care
Usual care- control group
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
65
|
67
|
75
|
73
|
|
Overall Study
COMPLETED
|
65
|
67
|
75
|
73
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Improving Obstructive Sleep Apnea Management Via Wireless Telemonitoring
Baseline characteristics by cohort
| Measure |
Self-management
n=65 Participants
Active Intervention
Self-management: Self-management
|
Telemonitored Care
n=67 Participants
Active Comparator
Telemonitored care: Telemonitored care
|
SM+TC
n=75 Participants
1+2
Self-management: Self-management
Telemonitored care: Telemonitored care
|
Usual Care
n=73 Participants
Usual care- control group
|
Total
n=280 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
56 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
241 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
271 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
65 participants
n=5 Participants
|
67 participants
n=7 Participants
|
75 participants
n=5 Participants
|
73 participants
n=4 Participants
|
280 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 3 mosNightly CPAP adherence hours per night measured over the three-months period
Outcome measures
| Measure |
Self-management
n=65 Participants
Active Intervention
Self-management: Self-management
|
Telemonitored Care
n=67 Participants
Active Comparator
Telemonitored care: Telemonitored care
|
SM+TC
n=75 Participants
1+2
Self-management: Self-management
Telemonitored care: Telemonitored care
|
Usual Care
n=73 Participants
Usual care- control group
|
|---|---|---|---|---|
|
Nightly CPAP Adherence
|
3.7 hours per night
Standard Deviation 1.8
|
3.7 hours per night
Standard Deviation 2.3
|
3.7 hours per night
Standard Deviation 2.2
|
3.2 hours per night
Standard Deviation 2.3
|
Adverse Events
Self-management
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Telemonitored Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SM+TC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
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