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Safety and Efficacy of an Ambulatory Biofeedback Device for Primary Insomnia

NCT ID: NCT00415714

Last Updated: 2007-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2007-10-31

Brief Summary

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The objective of this study is to determine the efficacy of a portable biofeedback device on improving sleep latency and other sleep variables such as nocturnal awake time and daytime functioning in persons with primary insomnia.

Detailed Description

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There is evidence that when compared to normal controls, persons with insomnia exhibit increased cognitive and physiological arousal and higher overall metabolic rate during sleep, particularly at sleep onset. There is evidence that reducing this arousal may impact sleep latency and nocturnal awake time. Although relaxation treatments have been integrated into behavioral therapies, there are numerous barriers to their implementation in real world settings. The present study is designed to examine the effect of a portable biofeedback device designed to induce physiological relaxation as compared to an inactive sham control device condition in reducing sleep onset latency in persons with primary insomnia over a 4 week period at three separate research sites.

Conditions

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Primary Insomnia

Keywords

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Primary Insomnia Chronic Insomnia Biofeedback Sleeplessness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Portable Biofeedback

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Between the ages of 18-55
2. Met DSM-IV-TR criteria for Primary Insomnia as measured by the:

* Structured Interview for Sleep Disorders.
* Insomnia Severity Index (\>14).
3. Demonstrate Sleep Onset Latency of \>=45 minutes on \>= 3 nights per week greater than or equal to 6 days over the 2 week period.
4. A mean SOL \>= 30 minutes over the 2 week period between Screening and Baseline visits.
5. Residential stability (1 year) and means to travel to appointments.
6. Willing to provide the name and contact information of a secondary contact person.
7. Off insomnia medications for at least one week prior to randomization and no more than 2 days of use during the first week of baseline.
8. Ability to read in English.
9. Provision of informed consent.
10. Willing to comply with daily protocol.
11. Ability to obtain a reading on the device.

Exclusion Criteria

1. Been in more than 2 studies in the past 2 years
2. Pregnant
3. Terminal, progressive, and or unstable medical illness.
4. Self-reported sleep disruptive medical disorder i. Chronic Pain, Fibromyalgia, Pheochromocytoma, Hyperthyroidism, Congestive Heart Failure, Chronic Obstructive Pulmonary Disease, Diabetes.
5. Current Axis I psychiatric disorder.(DSM-IV) i. Major Depressive Disorder, Depression, Generalized Anxiety Disorder, Attention Deficit Disorder, Post Traumatic Stress Disorder, Bipolar Disorder, Substance/Alcohol Use Disorders, Attention Deficit Hyperactivity Disorder, Schizophrenia/Psychotic Disorders, Delirium, Dementia, and/or Amnesic disorders, Panic Disorder w/ nocturnal panic attacks.
6. Chronic alcohol use not diagnosed in criterion 6. i. Subjects unwilling to limit their alcohol intake to 2 standard drinks per day will be excluded.
7. Raynaud's Disease
8. Regularly taking anti-anxiety medications, beta blockers or other heart medications that regulate heartbeat, bronchodilators, respiratory stimulants, simulating antidepressants, sedating antidepressants, thyroid supplements, anti-psychotics, and/or steroids.
9. Regularly taking antidepressants (Prozac, Zoloft, Paxil) and NOT on a fixed dosage for at least 1 month prior to entering the study.
10. Regularly taking medication (prescribed or over the counter) for sleep difficulties (\>3x week). Sleep medications include any substance for sleep not limited to but including FDA approved sleep medications, analgesics, antihistamines, decongestants, melatonin, L-trypotophan, and velarian.
11. Unwilling to abstain from PRN sleep aides (prescribed or over the counter).
12. Restless Leg Syndrome as assessed by structured interview.
13. Symptoms of Sleep Apnea (BMI\>32 and Epworth Sleepiness Scale \>10)
14. Own a negative air ionizer or have used one in the past to treat insomnia.
15. If subject recognizes device during the ability to obtain a pulse rate wave reading on the device.
16. More than 5 cups (8oz) of caffeinated drinks per day and/or unwilling to limit caffeine in-take to a maximum of 3 cups a day and not after 5pm during the intervention.
17. Regular night-time shift work and rotating night-time shift work.
18. Idiopathic Insomnia.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helicor

INDUSTRY

Sponsor Role lead

Principal Investigators

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Jack Edinger, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Duke Unversity Medical Center

Charles Morin, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Laval

Locations

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Duke University Medical Center

Durham, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Jack Edinger, Ph.D.

Role: primary

References

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Morin CM, Hauri PJ, Espie CA, Spielman AJ, Buysse DJ, Bootzin RR. Nonpharmacologic treatment of chronic insomnia. An American Academy of Sleep Medicine review. Sleep. 1999 Dec 15;22(8):1134-56. doi: 10.1093/sleep/22.8.1134.

Reference Type BACKGROUND
PMID: 10617176 (View on PubMed)

Related Links

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http://www.aasmnet.org/

Sleep website

Other Identifiers

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H300

Identifier Type: -

Identifier Source: org_study_id