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NCT02443649 · ClinicalTrials.gov registry record · NA
Improving Sleep Quality in People With Insomnia
A NA study, sponsored by Oregon Health and Science University.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
NCT02443649 is a NA study that has completed, run by Oregon Health and Science University. The registered enrollment target is 40 participants.
The verdict
NCT02443649, a NA study, has completed, sponsored by Oregon Health and Science University.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
Study Summary
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 fro
Interventions
- BEHAVIORAL Sleep hygiene program
- BEHAVIORAL Sleep hypnosis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2015-01 |
| Est. Completion | 2016-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02443649
The ClinicalTrials.gov registry entry for NCT02443649 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Oregon Health and Science University, which has 546 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Sleep hygiene program is the first listed.
NCT02443649 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02443649 about?
NCT02443649 is a clinical study titled "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 promi...
What is the current status of trial NCT02443649?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2015-01. Estimated completion is 2016-12.
What interventions are being tested in trial NCT02443649?
The interventions under investigation include: Sleep hygiene program (BEHAVIORAL), Sleep hypnosis (BEHAVIORAL).
Who is sponsoring clinical trial NCT02443649?
This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.
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