Safety and Efficacy of an Ambulatory Biofeedback Device for Primary Insomnia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by Helicor.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Helicor
ClinicalTrials.gov Identifier:
NCT00415714
First received: December 21, 2006
Last updated: January 26, 2007
Last verified: December 2006
  Purpose

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.


Condition Intervention
Primary Insomnia
Device: Portable Biofeedback

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: A Randomized Controlled Pilot Trial Testing the Safety and Efficacy of an Ambulatory Biofeedback Device for Primary Insomnia

Further study details as provided by Helicor:

Primary Outcome Measures:
  • Sleep latency at 4 week follow-up

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 132
Study Start Date: September 2006
Estimated Study Completion Date: October 2007
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00415714

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Jack Edinger, Ph.D.    919-681-8392    jack.edinger@duke.edu   
Sponsors and Collaborators
Helicor
Investigators
Principal Investigator: Jack Edinger, Ph.D. Duke Unversity Medical Center
Principal Investigator: Charles Morin, Ph.D. University of Laval
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00415714     History of Changes
Other Study ID Numbers: H300
Study First Received: December 21, 2006
Last Updated: January 26, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Helicor:
Primary Insomnia
Chronic Insomnia
Biofeedback
Sleeplessness

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on August 20, 2014