NCT00415714

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2006

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 25, 2006

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

January 29, 2007

Status Verified

December 1, 2006

First QC Date

December 21, 2006

Last Update Submit

January 26, 2007

Conditions

Primary Insomnia

Keywords

Primary InsomniaChronic InsomniaBiofeedbackSleeplessness

Outcome Measures

Primary Outcomes (1)

  • Sleep latency at 4 week follow-up

Secondary Outcomes (4)

  • wake time after sleep onset (WASO) at 4 week follow-up

  • total awake time (SOL + WASO) at 4 week follow-up

  • Shifting from moderate/severe insomnia to mild/no insomnia (Insomnia Severity Index)at 4 week follow-up

  • Daytime functioning at 4 week follow-up

Interventions

Portable BiofeedbackDEVICE

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Between the ages of 18-55
  • Met DSM-IV-TR criteria for Primary Insomnia as measured by the:
  • Structured Interview for Sleep Disorders.
  • Insomnia Severity Index (\>14).
  • Demonstrate Sleep Onset Latency of \>=45 minutes on \>= 3 nights per week greater than or equal to 6 days over the 2 week period.
  • A mean SOL \>= 30 minutes over the 2 week period between Screening and Baseline visits.
  • Residential stability (1 year) and means to travel to appointments.
  • Willing to provide the name and contact information of a secondary contact person.
  • 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.
  • Ability to read in English.
  • Provision of informed consent.
  • Willing to comply with daily protocol.
  • Ability to obtain a reading on the device.

You may not qualify if:

  • Been in more than 2 studies in the past 2 years
  • Pregnant
  • Terminal, progressive, and or unstable medical illness.
  • Self-reported sleep disruptive medical disorder i. Chronic Pain, Fibromyalgia, Pheochromocytoma, Hyperthyroidism, Congestive Heart Failure, Chronic Obstructive Pulmonary Disease, Diabetes.
  • 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.
  • 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.
  • Raynaud's Disease
  • 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.
  • Regularly taking antidepressants (Prozac, Zoloft, Paxil) and NOT on a fixed dosage for at least 1 month prior to entering the study.
  • 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.
  • Unwilling to abstain from PRN sleep aides (prescribed or over the counter).
  • Restless Leg Syndrome as assessed by structured interview.
  • Symptoms of Sleep Apnea (BMI\>32 and Epworth Sleepiness Scale \>10)
  • Own a negative air ionizer or have used one in the past to treat insomnia.
  • If subject recognizes device during the ability to obtain a pulse rate wave reading on the device.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 10617176BACKGROUND

Related Links

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Jack Edinger, Ph.D.

    Duke Unversity Medical Center

    PRINCIPAL INVESTIGATOR

  • Charles Morin, Ph.D.

    University of Laval

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 21, 2006

First Posted

December 25, 2006

Study Start

September 1, 2006

Study Completion

October 1, 2007

Last Updated

January 29, 2007

Record last verified: 2006-12

Locations

US(1)