Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000494639
Ethics application status
Approved
Date submitted
13/03/2013
Date registered
12/05/2014
Date last updated
20/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Light treatment for sleep and circadian disruption in kidney donor patients
Scientific title
Light treatment for sleep and circadian disruption in kidney donor patients
Secondary ID [1] 282116 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sleep disruption following surgery 288609 0
Condition category
Condition code
Neurological 288942 288942 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of administration of bright light (max. 10, 000 lux) for up 180 minutes during surgery. Light is delivered to the patient via a specifically designed human light mask.
Intervention code [1] 286719 0
Treatment: Other
Comparator / control treatment
The control treatment is 180 minutes of placebo light therapy. This is light is low intensity and of a wavelength which is known not to influence the circadian clock. Placebo light will be administered using a specifically design human light mask.
Control group
Placebo

Outcomes
Primary outcome [1] 289070 0
1. Sleep disruption (as defined by a combination of total sleep time and sleep fragmentation) will be calculated from actigraphic data using proprietary analysis software (Mini Mitter-Respironics).
Timepoint [1] 289070 0
All participants will have their sleep monitored (using the non-invasive wrist worn actiwatch devices) for seven days prior to seven and following surgery (total 14-15 days). Actigraphy will be measured using an actiwatch (which is a wrist worn device to monitor sleep wake rhythms and light exposure).
Actigraphic data will be analysed at at conclusion of the 14 days of data collection.
Secondary outcome [1] 301674 0
2. Determining the coordination of circadian rhythms from wrist worn actigraphy is in intradaily variability (IV), interdaily stability (IS), relative amplitude (RA). These circadian markers will be analysed using proprietary NPCRA software (Cambridge Neurotechnology).
Timepoint [1] 301674 0
Actigraphic data will be analysed at at conclusion of the 14 days of data collection
Secondary outcome [2] 302110 0
3. Circadian disruption (as defined by a change in phase or amplitude of the circadian marker 6-sulphatoxymelatonin).
The urinary levels of 6-Sulphatoxymelatonin, the major metabolite of melatonin (a6MTs) will be taken from participants’ urine for three days prior to surgery and three days following surgery. Urine will be collected in four-hourly bins throughout the day and in one overnight bin (approximately eight hours). At the conclusion of each time bin participants will be asked to fill out the 9-point Karolinksa Sleepiness Scale (KSS).
Timepoint [2] 302110 0
Urine samples (5 samples per day for three days prior to and three days following surgery- total 30 samples/patient) collected will be assayed using commercially available kits (Buhlmann Laboratories, Switzerland) for concentration of 6-Sulphatoxymelatonin at the conclusion of the study period. Robustness, phase and amplitude of melatonin rhythms will be analysed using cosinor methods (Chronos-fit).
Secondary outcome [3] 308093 0
4. Core body temperature profiles showing a phase shift and/or amplitude change.
Temperature will be monitored using ingestible pill devices which transmit data to a sensor belt worn around the chest (EquivitalTM and Vitalsense [Registered Trademark]). Participants will be asked to swallow an ingestible pill each morning (days -3 to 3) to record core body temperature continuously for six days total. On these days, participants will be asked to wear a wristband notifying healthcare providers of the presence of the pill in their gastrointestinal tract. Participants should not have an MRI without first eliminating the pill.
Timepoint [3] 308093 0
Core body temperature will be monitored continuously from day -3 to day 3 and will be analysed at the conclusion of the study using the inter-peak difference between the light group and the placebo light group post-operatively compared with pre-operatively.
Secondary outcome [4] 308173 0
Questionnaires of mood, fatigue and subjective sleep will be administered daily at 18:00 hours for the study period from 7 days prior to surgery (day -7) to 7 days after surgery (day 7) using the Piper’s Fatigue Scale (PFS), the Depression Anxiety Stress Scales (DASS) and subjective sleep diary.
Timepoint [4] 308173 0
Questionnaires administered daily at 18:00 hours daily for the study period from 7 days prior to surgery (day -7) to 7 days after surgery (day 7) will be scored as per standard methods. Differences in all of these variables will be tested between the two post-operative treatment groups using GLMs.
Secondary outcome [5] 308188 0
Daily pain assesments will be completed at 18:00 using a 10 cm visual analogue scale.
Timepoint [5] 308188 0
Daily pain assessments will be conducted at 18:00 h each day from -7 days to 7 days.

Eligibility
Key inclusion criteria
Patients must:
a)be scheduled for elective laproscopic nephrectomy surgery at Auckland City Hospital
b) be over 18 years of age.
c) provide written informed consent.
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients will be excluded if:
a) they do not meet the inclusion criteria.
b) they are already enrolled in another concurrent clinical trial.
c) A documented sleep condition which they have current active treatment for.
d) At the principal investigator’s discretion.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Forty patients scheduled to undergo donor nephrectomy will be recruited into the study where 20 of whom will be randomly assigned to receive ‘bright light administration’ and 20 of whom will receive ‘placebo light administration’. Allocation will be concealed until administration of light/placebo light at which time it will be evident to the investigators (but not the subjects who are anaesthetised) whether patients are in the placebo light or bright light group. The concealment will be conducted using opaque envelopes and a computer generated block randmoisation schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects will be randomised to treatment or placebo control. Sequences will be generated using block randomisation with a computer.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Forty patients scheduled to undergo donor nephrectomy will be recruited into the study where 20 of whom will be randomly assigned to receive ‘bright light administration’ and 20 of whom will receive ‘placebo light administration’. Based on data from previous studies we have conducted, a sample size of 40 patients will provide us with sufficient power to detect a statistically significant effect of intra-operative light administration on sleep and the circadian clock if one exists.
The efficacy of the light in reducing sleep and circadian disruption will be determined by analysing markers of sleep and circadian disruption (sleep time, sleep fragmentation, sleep timing, phase and robustness of melatonin and core body temperature rhythms) using GLMs.
Allocation concealment will be carried out using oqaue envelopes and a computer generated block randomisation schedule.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/07/2014
Actual
14/11/2014
Date of last participant enrolment
Anticipated
1/06/2017
Actual
11/04/2017
Date of last data collection
Anticipated
Actual
5/05/2017
Sample size
Target
40
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 4910 0
New Zealand
State/province [1] 4910 0
Auckland

Funding & Sponsors
Funding source category [1] 286884 0
Government body
Name [1] 286884 0
NICOP (Naval International Cooperative Opportunities in Science and Technology Program) basic biomedical grant from the Office of Naval Research in the United States of America
Country [1] 286884 0
United States of America
Primary sponsor type
University
Name
University of Auckland
Address
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 285674 0
None
Name [1] 285674 0
Address [1] 285674 0
Country [1] 285674 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288945 0
Health and Disability Ethics Committee (HDEC), New Zealand
Ethics committee address [1] 288945 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington 6011
Ethics committee country [1] 288945 0
New Zealand
Date submitted for ethics approval [1] 288945 0
13/03/2013
Approval date [1] 288945 0
02/04/2013
Ethics approval number [1] 288945 0

Summary
Brief summary
There is currently a shortage of kidneys for donation in New Zealand. Any measures that can improve the process of patients giving live donation of kidneys will help meet this shortage. Kidney donor patients pre-operatively are fit and well. Studies have shown that a laparoscopic (keyhole) approach to nephrectomy aids in a quick recovery. Despite this, in the follow up of these patients it appears that fatigue may persist post surgery. This may be due to sleep disturbance from the operation, anaesthetic and hospital stay. Surgery and anaesthesia are known to cause sleep disturbances and fatigue, in part due to a disturbance in the circadian clock which controls sleep. In a pilot study we are currently completing at Wellington hospital (approved by the central ethics committee) we have already shown that sleep and circadian rhythms are disrupted in kidney donor patients. In the current study we will extend these findings further with a protocol with higher resolution than used in the pilot. In addition we will also investigate the efficacy of light in treating this sleep and circadian disruption. We will recruit 40 patients scheduled to undergo laparoscopic donor nephrectomy surgery at Auckland City Hospital, and will monitor sleep and activity (using actiwatches), circadian rhythms (using urine samples) and fatigue and mood (using questionnaires) for three days prior to and three days after their surgery. Half of these patients will receive 180 minutes of light administration during surgery and half will receive placebo light administration. Data from these patients will provide a clear understanding of the extent of sleep disruption and mood reduction which is attributable to hospitalization and surgery, and importantly the efficacy of light therapy in treating/preventing this disruption.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38450 0
A/Prof Guy Warman
Address 38450 0
Dept Anaesthesiology
School of Medicine
Faculty of Medical and Health Sciences (FMHS)
University of Auckland
Private Bag 92019
Auckland 1142
Country 38450 0
New Zealand
Phone 38450 0
+6493737599
Fax 38450 0
+6493737970
Email 38450 0
[email protected]
Contact person for public queries
Name 38451 0
A/Prof Guy Warman
Address 38451 0
Dept Anaesthesiology
School of Medicine
Faculty of Medical and Health Sciences (FMHS)
University of Auckland
Private Bag 92019
Auckland 1142
Country 38451 0
New Zealand
Phone 38451 0
+6493737599
Fax 38451 0
+6493737970
Email 38451 0
[email protected]
Contact person for scientific queries
Name 38452 0
A/Prof Guy Warman
Address 38452 0
Dept Anaesthesiology
School of Medicine
Faculty of Medical and Health Sciences (FMHS).
University of Auckland
Private Bag 92019
Auckland 1142
Country 38452 0
New Zealand
Phone 38452 0
+6493737599
Fax 38452 0
+6493737970
Email 38452 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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