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Primary InsomniaNCT00415714

Safety and Efficacy of an Ambulatory Biofeedback Device for Primary Insomnia

A study testing Portable Biofeedback in people with Primary Insomnia, run by Helicor at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Primary Insomnia
What is being tested?
Portable Biofeedback
Type of treatment
Medical device
How many people
132 participants
Where
1 siteUnited States
Study dates
Sep 2006to Oct 2007
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • 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.
  • Regular night-time shift work and rotating night-time shift work.
  • Idiopathic Insomnia.

Trial locations and contacts

1 site in 1 country.

United States1 site, 1 recruiting

  • Duke University Medical Center

    Durham, North Carolina, 27710

    Jack Edinger, Ph.D., 919-681-8392, jack.edinger@duke.edu

    Recruiting

Other trials in United States

About this study

Official title: A Randomized Controlled Pilot Trial Testing the Safety and Efficacy of an Ambulatory Biofeedback Device for Primary Insomnia

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.

Read the 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.

Being tested
Portable Biofeedback
Keywords
Primary Insomnia, Chronic Insomnia, Biofeedback, Sleeplessness
Medical subject headings
Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Portable BiofeedbackDevice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sleep latency at 4 week follow-up

Secondary outcomes (4)

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

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

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

  4. Daytime functioning at 4 week follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Dec 2006 (estimated)
  2. Study startSep 2006
  3. Study completionOct 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Enrolment
132 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00415714
Sponsor's protocol ID
H300
Status last verified
Dec 2006
First submitted
21 Dec 2006
Last updated
29 Jan 2007
Results posted
No

Publications

  • 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.

    PubMed 10617176

Questions about this trial

What is this clinical trial studying?

A study testing Portable Biofeedback in people with Primary Insomnia, run by Helicor at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sleep latency at 4 week follow-up. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00415714, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2007.

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