Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04633668 |
| Other study ID # |
Umanitoba1 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2021 |
| Est. completion date |
April 30, 2022 |
Study information
| Verified date |
May 2022 |
| Source |
University of Manitoba |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This research aims to determine whether cognitive behavioral therapy can effectively reduce
parasomnias in a sample of 20 adult outpatients with Non-REM and REM parasomnias. A secondary
objective is to assess whether treatment produces improvements in daytime energy, mood, and
anxiety symptoms, as well as functional impairment (work/leisure activities).
Description:
Sleep wake disorders are prevalent and impactful conditions often poorly assessed and
sub-optimally treated in the clinical setting. Undiagnosed sleep disorders can masquerade as
mental health conditions and worsen the outcomes associated with these conditions. Further,
sleep disorders can develop from mental health conditions and the reverse is also true
(particularly for mood disorders). Successful treatment of sleep disorders requires a
targeted approach.
Parasomnias are unwanted physical or mental events that occur during sleep or during arousal
from sleep. The states of wakefulness, NREM, and REM are normally distinct and occur in an
organized and predictable pattern over the 24-hour period. However, in parasomnias, aspects
of more than one state co-occur and intermix. There are four types of parasomnias identified
by the Diagnostic and Statistical Manual of Mental Disorders ( DSM 5). These include two NREM
parasomnias: sleepwalking and sleep terrors, and two REM parasomnias: nightmare disorder and
REM sleep behaviour disorder (RSBD). Lifetime prevalence of these conditions ranges from 6.9%
(sleepwalking) to 67% (nightmare disorder).
In general, NREM parasomnia events are primed by conditions that increase sleep pressure and
triggered by sleep-disrupting factors. They are more likely to occur following sleep
restriction or deprivation, when SWS rebounds. Immediate triggers of sleepwalking in adults
are sleep disruptions associated with sleep-disordered breathing, periodic limb movements,
noises and touch. Pilon et al. induced episodes in adult sleepwalkers, but not in
non-sleepwalkers, with specific auditory stimuli and this effect was accentuated under
conditions of prior sleep deprivation.
Currently accepted interventions for parasomnias include pharmacological and psychological
treatments. Pharmacological interventions involve the use of sedating medications
(benzodiazepines, tricyclic antidepressants) or alpha-1 blocker (Prazosin).
Cognitive Behavioral Therapy. Psychological treatments primarily rely on cognitive behavioral
therapy to achieve better sleep hygiene, reduced hyperarousal, and to teach the ability to
practice with reducing cognitive arousal during the sleep period through planned rehearsal
and scheduled awakenings. There are no well elaborated and systematic treatment packages for
Non-REM parasomnias and so this protocol will represent an innovation in this area.
Therefore, the purpose of the study is to develop and test such a package.
Self-Monitoring of Sleep. Self-monitoring of disturbed sleep has been shown to produce small
but significant positive impacts on some aspects of sleep (e.g., insomnia). As there is no
widely accepted placebo for parasomnia treatment, this is viewed as an adequate control
condition.
Objectives This research aims to determine whether cognitive behavioral therapy can
effectively reduce parasomnias in a sample of 20 adult outpatients with Non-REM and REM
parasomnias. A secondary objective is to assess whether treatment produces improvements in
daytime energy, mood, and anxiety symptoms, as well as functional impairment (work/leisure
activities). The hypotheses of the study are that participants who receive a 6-week program
CBT-p therapy will report fewer episodes of parasomnia than those who self-monitor their
sleep for 6 weeks, and will have objectively better sleep as measured by the prodigy and
actigraphy at one-week (T2) post treatment and at two months post treatment (T3).
METHODS Trial Design This will be a single-blind randomized controlled trial with two
conditions.
