Improving Sleep Quality in People With Insomnia

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.

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)