Trial Outcomes & Findings for Light for Renal Transplant Recipients Having a Sleep-Wake Dysregulation (NCT NCT01256983)

Last Updated: 2014-03-03

Results Overview

The mean "bedtime" assessed by actimetry of each 3 week period (day 21, 42, 63 ) was used as outcome to be compared with the control group. Bedtime is expressed in time (hours and minutes)

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

30 participants

Primary outcome timeframe

Mean Bedtimes over 21 days for each period

Results posted on

2014-03-03

Participant Flow

49 patients were recruited

19 declined to participate after initial interest

Participant milestones

Participant milestones
Measure	Light Box 10000 lux after day 21 Light Box : 10000 Lux for 30 Minutes according to sleep wake rhythm	No Intervention 10000 Lux after day 63
Overall Study STARTED	15	15
Overall Study COMPLETED	14	12
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Light for Renal Transplant Recipients Having a Sleep-Wake Dysregulation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total n=30 Participants Total of all reporting groups	Light Box n=15 Participants 10000 lux after day 21 Light Box : 10000 Lux for 30 Minutes according to sleep wake rhythm	No Intervention n=15 Participants 10000 Lux after day 63
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=5 Participants	13 Participants n=5 Participants	14 Participants n=7 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	2 Participants n=5 Participants	1 Participants n=7 Participants
Age, Continuous	59.63 years STANDARD_DEVIATION 12.65 • n=5 Participants	60.72 years STANDARD_DEVIATION 10.33 • n=5 Participants	58.54 years STANDARD_DEVIATION 14.91 • n=7 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	7 Participants n=5 Participants	8 Participants n=7 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	8 Participants n=5 Participants	7 Participants n=7 Participants
Region of Enrollment Switzerland	30 participants n=5 Participants	15 participants n=5 Participants	15 participants n=7 Participants

PRIMARY outcome

Timeframe: Mean Bedtimes over 21 days for each period

The mean "bedtime" assessed by actimetry of each 3 week period (day 21, 42, 63 ) was used as outcome to be compared with the control group. Bedtime is expressed in time (hours and minutes)

Outcome measures

Outcome measures
Measure	Light Box n=14 Participants 10000 lux after day 21 Light Box : 10000 Lux for 30 Minutes according to sleep wake rhythm	No Intervention n=12 Participants 10000 Lux after day 63
Bedtime Getup time	7.44 Hours Standard Deviation 1.69	7.24 Hours Standard Deviation 1.39
Bedtime Bedtime	22.98 Hours Standard Deviation 1.78	22.48 Hours Standard Deviation 1.37

Adverse Events

Bright Light Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Wait-list Intervention

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

Mrs. Hanna Burkahlter

University Hospital Zürich

Phone: 0041 76 371 12 35

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place