Psychophysiological Insomnia clinical trials

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