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Sleep restriction for the treatment of primary insomnia in primary care

In those with primary insomnia is modified sleep restriction better than control for improving sleep quality?

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12609000127202
Acronym
REFRESH: REstriction For REorganising Sleep Habits
Enrollment
100
Registered
2009-02-23
Start date
2009-03-10
Completion date
2012-05-19
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

There are limited options for treating primary insomnia in the primary care (general practice/family medicine) setting. Cognitive behavioural therapy (CBT), a multicomponent treatment has shown to be effective. However, there is limited access to this treatment as trained practitioners are often scarce, acceptability is often problematic as it involves 1-2hours sessions for a number of weeks, and cost poses a real financial barrier. Added to this, the family doctor is unable to treat their patient at the point of care. Sleep restriction is one of the components of the multicomponent CBT. Our hypothesis is that this is the most effective component. This study will be testing if sleep restriction is effective as a stand-alone treatment for primary insomnia in the primary care setting.

Interventions

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 tim

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.

Sponsors

University of Auckland
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
16 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

Age 16-75, Primary insomnia lasting greater than 6 months, able to understand English

Exclusion criteria

Presence of alternate sleep disorder, major medical or psychiatric illness, medically unstable

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026