Primary Insomnia Clinical Trial
Official title:
Improving Sleep Quality in People With Insomnia
Insomnia is a significant problem affecting 10 to 20% of US population. Long-term
pharmacological treatments are not recommended due to side effects, with therapy and sleep
hygiene education often employed as alternatives. Use of mind-body approaches for insomnia
is increasing. One of the most promising mind-body approaches for alleviating sleep problems
is hypnosis. Research indicates significant beneficial effects of hypnosis on sleep, but
sleep was rarely assessed as primary outcome and studied populations were diverse. Further,
it remains unclear who the best candidates for benefitting from hypnosis are. To address
some of the gaps in the current knowledge, the study evaluates whether 1) an addition of
hypnotic suggestion for sleep improvement to the optimizing sleep hygiene (OSH) program
increases the effectiveness of the OSH using objective and subjective assessments and 2)
determines characteristics associated with hypnotic responsiveness.To address these goals a
randomized controlled trial (RCT) with 3 laboratory visits (baseline, intervention, and 1
month follow-up) will be conducted with 50 adults meeting criteria for primary insomnia and
allocated to one the two groups: 1) experimental group receiving during the intervention
visit a combination of the Optimizing Sleep Hygiene (OSH) program and a hypnosis session for
sleep improvement and 2) a control group receiving at the intervention visit the OSH only.
Hypnosis session for sleep improvement for the control group will be offered at the end of
the follow-up study visit (conducted after 4 weeks post-intervention) after completing all
follow-up measures. Each study visit will last for 2-3 hours. During the visits sleep,
personality traits and daily function of the participants will be assessed. Further, after
the baseline and one week before the follow-up visit subjects will wear a watch-like
actigraphic device monitoring their sleep patterns at home and will complete sleep diary.
The knowledge gained from this study will inform the literature and clinicians about
usefulness of hypnosis for insomnia sufferers and will help identify the population of
insomnia sufferers most likely benefit from use of hypnosis for sleep
Status | Completed |
Enrollment | 40 |
Est. completion date | December 2016 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 25 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Age 25 or older - Primary insomnia diagnosis - Able to attend all study sessions and willing to complete the study requirements - Fluent English - Able and willing to consent Exclusion Criteria: - Current use of hypnosis with hypnotist - Other diagnosed sleep disorders - Other serious illness (e.g. cancer, major depression, chronic pain condition etc.) - Problem hearing - Pregnancy - Use of illicit drugs or alcohol use in excess of what constitutes moderate drinking (>1 drink per day for women and >2 drinks per day for men) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Oregon Health & Science University | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
Oregon Health and Science University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sleep efficiency change at one-month follow-up (from baseline) | actigraphic sleep efficiency | collected at baseline and one-month follow-up | No |
Secondary | Functional outcomes of sleep score change at one-month follow-up (from baseline) | Functional outcomes of sleep score collected at baseline and follow-up through FOSQ | collected at baseline and one-month follow-up | No |
Secondary | Sleep Hygiene score change at one-month follow-up (from baseline) | Sleep Hygiene Index instrument score | collected at baseline and one-month follow-up | No |
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