Improving Sleep Quality in People With Insomnia
Condition: Primary Insomnia; Psychophysiological Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

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 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
    

Detailed description: 
      1. Protocol Title Improving sleep quality in people with insomnia

        2. Objectives The purpose of the study is to compare effectiveness of two sleep improvement
           programs for people with primary psychophysiological insomnia: 1) the Optimizing Sleep
           Hygiene (OSH) program and 2) a combination of the OSH and hypnosis for sleep
           improvement. The goals of this study are: 1) using objective and subjective assessments
           to evaluate whether an addition of hypnotic suggestion for sleep improvement to the
           sleep hygiene program increases the effectiveness of the OSH, and 2) to determine
           subject characteristics associated with hypnotic responsiveness in adults with primary
           psychophysiological insomnia.

           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 psychophysiological 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. One-month follow-up
           visit will be conducted following at least 4 weeks since the intervention visit.
           Hypnosis session for sleep improvement for the control group will be offered at the end
           of the follow-up study visit after completing all follow-up measures. Each study visit
           will last for 2-3 hours. During the visits participants' personality traits, hypnotic
           susceptibility as well as measures of insomnia severity, sleep quality, hygiene, and
           daily function will be assessed. Further, between the visits at home subjects will wear
           a watch-like actigraphic device monitoring their day and night activity. These
           actigraphic recordings will allow for collecting objective actigraphic measures of
           sleep. The actigraphic measures will be collected along with daily sleep and medications
           diaries for periods of 7 days immediately after the baseline assessment and 1 week prior
           to one-month follow-up assessment. Additionally, during the one-month follow-up visit,
           patterns of brain activity will be monitored in all subjects first when they listen to a
           neutral sleep-related recording and then during listening to a recording of hypnosis for
           sleep improvement. The purpose of these measures is to compare brain activity patterns
           and identify specific biomarkers of hypnotic state. Four weeks after the completion of
           all study visits participants will provide information about their sleep and their
           experiences with the study interventions components via a telephone or on-line
           assessment depending on their choice.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 most likely benefit from use of hypnosis for sleep.
           The goals of the proposal will be addressed by the following specific aims:

           Specific Aim 1: Compare changes from baseline in sleep parameters at the one-month
           follow-up visit between the two study groups (experimental and control) after exposure
           to the interventions.

           Hypothesis: Greater improvements in actigraphic and subjective sleep parameters and
           daily function will be observed in the experimental group compared to the control group.

           Specific Aim 2a: Identify characteristics correlating with changes in measures of sleep
           quality to describe a population that can potentially benefit from hypnosis.

           Hypothesis: Several sleep-specific variables (e.g. specific baseline insomnia symptoms
           and sleep hygiene problems) and personality features (e.g. hypnotic susceptibility and
           specific personality traits) will correlate with post-intervention changes in sleep
           variables.

           Specific Aim 2b: Identify characteristics correlating with hypnotic susceptibility for
           creating a scale that can be used in a clinic to assess hypnotic responsiveness for
           sleep-related problems.

           Hypothesis: Using the items from the instruments given during the study identified as a
           part of Specific Aim 2a short instrument could be constructed that can quickly and
           reliably categorize people based on their hypnotic responsiveness for sleep-related
           problems.

           Specific Aim 3: Assess brain wave patterns concurrent with hypnosis to identify
           psychophysiological markers specific to hypnotic state in order to describe mechanisms
           underlying hypnosis.

           Hypothesis: Based on the differences between the two states: 1) listening to hypnosis
           and 2) listening to a neutral sleep-related recording, brain activity markers that can
           distinguish state of hypnosis from the state of listening to a neutral recording could
           be identified.

           Background Insomnia, characterized by non-restorative sleep or by difficulty in
           initiating or maintaining sleep, is a significant problem affecting 10 to 20% of US
           population. Poor sleep impairs cognitive and immune functions, mood and productivity of
           sufferers and can increase risk for hypertension, diabetes, cancer and overall
           mortality. Long-term pharmacological insomnia treatment is not recommended due to side
           effects, with therapy and sleep hygiene education often employed as alternatives. There
           is also a growing interest in using mind-body approaches for managing sleep problems.
           Mind-body approaches are becoming popular due to accessibility and low side effect
           profile, as well as due to increasing amount of research evidence indicating their
           effectiveness. For example, a recent review of mind-body methods for improving sleep
           revealed that among the most promising mind-body approaches for alleviating sleep
           problems was hypnosis. Hypnosis is a state of relaxation combined with highly focused
           attention and characterized by dissociation of competing thoughts and sensations towards
           the periphery of awareness. One way to achieve hypnotic state is through an induction
           procedure typically followed by hypnotic suggestions or statements intended to elicit
           behavioral change. Efficacy of hypnosis has been demonstrated for several conditions,
           most notably for decreasing pain and alleviating stress-related disorders. Using
           hypnosis for sleep improvement is still a developing area of research. Though several
           studies found significant beneficial effects of hypnosis on sleep, most studies used
           hypnosis for alleviating other problems influencing sleep (e.g. hot flashes) rather than
           specifically targeting sleep as the primary focus of improvement. Moreover, majority of
           the studies on sleep and hypnosis used only subjective measures for evaluating sleep
           quality. Further, it remains unclear who the best candidates for benefitting from
           hypnosis are and how hypnotic responsiveness can be assessed in a clinic without lengthy
           tests of hypnotic susceptibility. To address some of the gaps in the current knowledge,
           the goals of this study are: 1) using objective and subjective assessments to evaluate
           whether an addition of hypnotic suggestion for sleep improvement to the sleep hygiene
           education program increases the program effectiveness, and 2) to determine subject
           characteristics associated with hypnotic responsiveness in adults with primary
           psychophysiological insomnia.

        3. Design: The planned study is a single-blind two-arm randomized controlled trial (RCT)
           with three study visits (baseline, intervention, and one-month follow-up), with
           participants randomly assigned to receive Optimizing Sleep Hygiene (OSH) program as an
           intervention either alone or in conjunction with hypnosis for sleep improvement during
           the intervention visit.
    

Intervention name(s): Sleep hygiene program; Sleep hypnosis
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Sleep hygiene program; Hypnosis recording with personalized goals and imagery for sleep improvement
Other intervention name(s): Hypnosis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment