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Trial registered on ANZCTR


Registration number
ACTRN12609000127202
Ethics application status
Approved
Date submitted
23/01/2009
Date registered
23/02/2009
Date last updated
8/04/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Sleep restriction for the treatment of primary insomnia in primary care
Scientific title
In those with primary insomnia is modified sleep restriction better than control for improving sleep quality?
Secondary ID [1] 282273 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
REFRESH: REstriction For REorganising Sleep Habits
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary Insomnia 4231 0
Condition category
Condition code
Other 4451 4451 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Restricting time in bed to time actually spent asleep according to sleep diary information. Initially subjects will be instructed to adjust their bed times and waking times (keeping waking time consistent) so that time in bed (TIB) is reduced by 50% of excess wakefulness. This is calculated using the average of 2 weeks of sleep diary information. That is, average time in bed - average sleep time = average wake time. Participants are initially instructed to subtract half the average amount of time spent awake from their average time in bed, giving their bedtime allowance. Bedtime is adjusted, morning arising is kept constant. E.g. If sleep diary information shows: 9h (average time in bed) - 6h (average sleep time) = 3h (average wake time) then 9h (average time in bed) -1.5h (half average wake time)= 7.5h (time allowed in bed) so bedtime would be adjusted to 1.5h later than usual. This regimen is followed for two weeks during which time a sleep diary is kept. The average sleep and wake times are then reviewed at an appointment with the researcher at the two week mark - if sleep efficiency has not improved to the point where the sleep efficiency falls between the desired range of 85-90%, time allowed in bed is further restricted so that average time in bed = average time spent asleep. If sleep is >90% efficient or daytime sleepiness is worse, 30 minutes is added to the time allowed in bed. The new instructions are given which the participant is instructed to follow nightly for two weeks before making a self-assessment and adjustment of their sleep. No further sleep diaries/actigraphy are required until outcome measures at 6 months. Participants are given a handout with the sleep self-adjustment algorithm which they use to adjust their sleep themselves every fortnight. This algorithm does not require calculations but requires a self assessment of sleep and daytime functioning. The algorithm adjusts bedtimes by +30 minutes, -30minutes or no change. Fortnightly readjustment of sleep by the participant continues until completion of the intervention at 6 months, at which time 2 weeks of sleep diary/actigraphy are recorded and outcomes assessed. This group also receives the handout of modified sleep hygiene instructions.
Intervention code [1] 3950 0
Treatment: Other
Comparator / control treatment
Modified sleep hygiene instructions are used as an active control so that time spent with the investigator and receiving instructions is matched to that given to the intervention group. Sleep hygiene is not thought to be an effective treatment for insomnia as a single treatment. The instructions are made more benign by avoiding giving any instructions about naps or consistent sleep schedules. Participants have already been screened for the exclusion criteria of 'insomnia due to inadequate sleep hygiene' to make this comparison intervention as inactive as possible. The instructions are as follows:
1) limit use of caffeine, alcohol, cigarettes
2) avoid vigorous exercise in the 3-4 hours before bedtime
3) minimise excessive noise, light temperature in the bedroom. Ensure bed is not too hard or soft
4) Avoid heavy meals or spicy foods at night
5) Taking a warm bath or having a hot drink (milk) can aid with sleep
6) Use the bedroom only for sleep and intimacy. Do not work in the bedroom
7) Use a bedtime ritual to get you in a relaxed mode for bedtime.
These instructions are given as a handout and verbally explained by the investigator at randomisation. The participants are instructed to follow this advice nightly. A sleep diary is recorded for two weeks prior to randomisation and for the first two weeks of the trial. After two weeks of following the instructions nightly, the participants are reviewed and the instructions are reiterated. Thereafter, participants are asked to continue to follow the instructions on a nightly basis until they are seen at the conclusion of the trial at 6 months. Two weeks of sleep dairy and actigraphy recording are made at this point, and outcome measures recorded. The time spent with the investigator and the timing of these contacts are matched between the intervention and control groups. Contact time between participant and investigator during these contact time is recorded using a stopwatch to allow verification of this matching.
Control group
Active

Outcomes
Primary outcome [1] 5333 0
Sleep Quality a) Subjective as measured by Pittsburgh Sleep Quality Index (PSQI) and by the Insomnia Severity Index (ISI) b) Objective as measured by Sleep efficiency (SE), total sleep time (TST), sleep onset latency (SOL) and wake after sleep onset (WASO) - derived from sleep diary and actigraphic data.
At 3 months diagnostic crietria for insomnia, PSQI and ISI assessed using mail out. At 6 months these measures are repeated along with a two week collection of sleep diary and actigraphy data.
Timepoint [1] 5333 0
3 months, 6 months
Secondary outcome [1] 8963 0
Sleepiness - measured using the Epworth Sleepiness Score
Timepoint [1] 8963 0
6 months
Secondary outcome [2] 8964 0
Mood
a) Depression - as measured by the -item Patient Health QUestionniare (PHQ-9)
b) Anxiety - as measured by the 7-item Generalised Anxiety Disorder Scale (GAD-7)
Timepoint [2] 8964 0
6 months
Secondary outcome [3] 8965 0
Fatigue - measured using the Flinders Fatigue Score
Timepoint [3] 8965 0
6 months
Secondary outcome [4] 9216 0
Adverse events:
a) incidence of acute coronary syndrome and cerebrovascular events
b) Hospital admissions
c) Accidents (minor/major-requiring medical attention)
d) change in resting heart rate and blood pressure
Timepoint [4] 9216 0
Week 3, 6 months

Eligibility
Key inclusion criteria
Age 16-75, Primary insomnia lasting greater than 6 months, able to understand English
Minimum age
16 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Presence of alternate sleep disorder, major medical or psychiatric illness, medically unstable

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2009
Actual
10/03/2009
Date of last participant enrolment
Anticipated
Actual
19/05/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 1546 0
New Zealand
State/province [1] 1546 0

Funding & Sponsors
Funding source category [1] 4412 0
Government body
Name [1] 4412 0
Health Research Council of New Zealand
Country [1] 4412 0
New Zealand
Funding source category [2] 4413 0
Charities/Societies/Foundations
Name [2] 4413 0
Royal New Zealand College of General Practitioners (RNZCGP) Research Trust
Country [2] 4413 0
New Zealand
Funding source category [3] 287040 0
Charities/Societies/Foundations
Name [3] 287040 0
The University of Auckland School of Medicine Foundation
Country [3] 287040 0
New Zealand
Funding source category [4] 287041 0
Charities/Societies/Foundations
Name [4] 287041 0
The Royal New Zealand College of General Practitioners Auckland Faculty Board Charitable Trust
Country [4] 287041 0
New Zealand
Funding source category [5] 287042 0
Charities/Societies/Foundations
Name [5] 287042 0
The Royal New Zealand College of General Practitioners
Research and Education Charitable Trust
Country [5] 287042 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Department of General Practice and Primary Health Care
University of Auckland
Private Bag 92 019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 3971 0
None
Name [1] 3971 0
Address [1] 3971 0
Country [1] 3971 0
Other collaborator category [1] 538 0
Individual
Name [1] 538 0
Professor Bruce Arroll
Address [1] 538 0
Department of General Practice and Primary Health Care
Private Bag 92 019
Auckland 1142
Country [1] 538 0
New Zealand
Other collaborator category [2] 539 0
Individual
Name [2] 539 0
Dr Antonio Fernando III
Address [2] 539 0
Department of Psychological Medicine
University of Auckland
Private Bag 92 019
Auckland 1142
Country [2] 539 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6461 0
Northern X Regional Ethics Committee
Ethics committee address [1] 6461 0
Ethics committee country [1] 6461 0
New Zealand
Date submitted for ethics approval [1] 6461 0
Approval date [1] 6461 0
24/04/2008
Ethics approval number [1] 6461 0
NTX/08/02/003

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29215 0
Dr Karen Falloon
Address 29215 0
Department of General Practice and Primary Health Care University of Auckland Private Bag 92 019 Auckland 1142
Country 29215 0
New Zealand
Phone 29215 0
64 9 373 7599
Fax 29215 0
Email 29215 0
k.falloon@auckland.ac.nz
Contact person for public queries
Name 12462 0
Karen Falloon
Address 12462 0
Department of General Practice and Primary Health Care
University of Auckland
Private Bag 92 019
Auckland 1142
Country 12462 0
New Zealand
Phone 12462 0
+64 9 373 7599
Fax 12462 0
Email 12462 0
k.falloon@auckland.ac.nz
Contact person for scientific queries
Name 3390 0
Karen Falloon
Address 3390 0
Department of General Practice and Primary Health Care
University of Auckland
Private Bag 92 019
Auckland 1142
Country 3390 0
New Zealand
Phone 3390 0
+64 9 373 7599
Fax 3390 0
Email 3390 0
k.falloon@auckland.ac.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.