Trial Outcomes & Findings for Comparison of 2 Different Hook-up Protocols to Perform Home-based Polysomnography (NCT NCT01361854)
NCT ID: NCT01361854
Last Updated: 2015-06-08
Results Overview
failure rate of polysomnography according to the hook-up protocol. Polysomnographies scored as "poor" or "unsatisafctory" according to Redline et al. SLEEP 1998 are considered as failed.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
102 participants
Primary outcome timeframe
1 day
Results posted on
2015-06-08
Participant Flow
Participant milestones
| Measure |
Home Hook-up First Then Hook-up in the Hospital
adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography
polysomnography: home-based polysomnography with hook-up performed at home first.
Croosover design. 2nd polysomnography with in-lab hook-up performed within 2 weeks
|
Hospital Hook-up First, Then Home Hook-up
adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography
polysomnography: home-based polysomnography with hook-up performed at the hospital Croosover design. 2nd polysomnography with home hook-up performed within 2 weeks
|
|---|---|---|
|
Day 1
STARTED
|
51
|
51
|
|
Day 1
COMPLETED
|
47
|
48
|
|
Day 1
NOT COMPLETED
|
4
|
3
|
|
Wash-out, Maximum 2 Weeks
STARTED
|
47
|
48
|
|
Wash-out, Maximum 2 Weeks
COMPLETED
|
47
|
48
|
|
Wash-out, Maximum 2 Weeks
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
47
|
48
|
|
Second Intervention
COMPLETED
|
47
|
48
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of 2 Different Hook-up Protocols to Perform Home-based Polysomnography
Baseline characteristics by cohort
| Measure |
Polysomnography for Suspicion of SDB
n=102 Participants
adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography
polysomnography: home-based polysomnography with hook-up performed ar at home or in the hospital
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
102 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
48 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
102 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 dayfailure rate of polysomnography according to the hook-up protocol. Polysomnographies scored as "poor" or "unsatisafctory" according to Redline et al. SLEEP 1998 are considered as failed.
Outcome measures
| Measure |
Home Hook up First
n=47 Participants
adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography
polysomnography: home-based polysomnography with home hook-up first
|
Lab Hook up First
n=48 Participants
adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography
polysomnography:home polysomnography with in-lab hook up first
|
|---|---|---|
|
Failure Rate of Sleep Study
|
6 percentage of participants
|
6 percentage of participants
|
Adverse Events
Home Hook up First
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lab Hook up First
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