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OpenTrials
Completed

NCT Number: NCT01790256

Comparison of Two Temperatures to Treat Insomnia

Insomnia patients demonstrate subjective and physiological hyperarousal. The Cereve Sleep System has been proposed as a clinical treatment to reverse this hyperarousal in insomnia patients. The current study is a two dose study to determine the optimal temperature for the Cereve Sleep System. Primary outcome measures include EEG sleep measured sleep latency and sleep efficiency.

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Key information

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Paul Wylie, Little Rock, Arkansas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age >/= 22

Diagnosis of insomnia that meets criteria for DSM IV diagnosis of primary insomnia and International Classification of Sleep Disorders (ICSD)general insomnia criteria and RDC insomnia disorder criteria

Subjects must remain alcohol-free and avoid drugs that could affect sleep during the study.

>14 on the Insomnia Severity Index

Sleep -Wake diaries demonstrate sleep efficiency <85% on at least 50% of nights

Exclusion criteria

Neuropsychiatric disorders that may independently affect sleep, brain function or cognition, such as current major syndromal psychiatric disorders, including DSM-IV mood, anxiety, psychotic, and substance use disorders.

Specific exclusionary diagnoses include major depressive disorder, dysthymic disorder, bipolar disorder, panic disorder, obsessive compulsive disorder, generalized anxiety disorder, any psychotic disorder, and any current substance use disorder.

Unstable medical conditions Raynaud's Disease

Irregular sleep schedules including shift workers;

A latency to persistent sleep < 15 on either the sleep disorder screening night or the baseline PSG sleep night;

A sleep efficiency > 85% on either the sleep disorder screening night or the baseline PSG sleep night;

An AHI (apnea hypopnea index) > 10 and/or a periodic limb movement arousal index (PLMAI) > 15 from SN1

Body Mass Index >34

Use of medications known to affect sleep or wake function

Consumption of more than one alcoholic drink per day, or more than 7 drinks per week prior to study entry.

Caffeinated beverages > 4/day or the equivalent of more than 4 cups of coffee Unable to read or understand English

Treatment and study plan

Cereve Sleep System at 30 degrees C

Device

Cereve Sleep System at 14-16 degrees C

Device

Primary outcomes

  1. Polysomnographically determined sleep latency as changed from baseline measures

    Time frame: 1-2 weeks

    Polysomnographically determined sleep parameters

  2. Poloysomnographically determined sleep efficiency as changed from baseline measures

    Time frame: 1-2 weeks

Sponsors and collaborators

Lead sponsor

Cereve, Inc.

Industry

Registry information

Official study title

A Multi-center Prospective, Blinded, Randomized Crossover Study to Compare the Cerêve Sleep System at Two Different Temperatures in Primary Insomnia Patients

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 13, 2013
Registry last updated
May 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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