← Back to Search

Self-help Treatment

Tech-Assisted Self-Help vs Manual Self-Help for Insomnia

N/A
Waitlist Available
Led By Bradford W Applegate, Ph.D.
Research Sponsored by PICS, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must have insomnia symptoms at least 3 days per week
Symptoms present for at least 6 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial will help researchers understand if a handheld computer can better help people with chronic primary insomnia than a self-help manual.

Who is the study for?
This trial is for adults who've been struggling with chronic insomnia, sleeping less than 6.5 hours a night for at least six months and have trouble falling or staying asleep at least three times a week. It's not suitable for those with other mental disorders, severe obesity, anxiety disorders, substance use issues, or other sleep conditions like apnea or narcolepsy.Check my eligibility
What is being tested?
The study is testing if using a handheld computer can help people manage their chronic insomnia better than following advice from a self-help manual. Participants will be randomly assigned to one of these two non-drug treatments to compare effectiveness.See study design
What are the potential side effects?
Since the interventions are non-drug treatments (handheld computer vs. self-help manual), there are no direct medical side effects expected from this trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I experience insomnia symptoms at least 3 days a week.
Select...
My symptoms have been present for at least 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in sleep parameters via polysomnography
Changes in sleep parameters via self-reported sleep diary
Changes in symptom severity as measured by Insomnia Severity Index
+2 more
Secondary outcome measures
Mental Depression
Changes in quality of life as measured by a qualitative instrument
Usability of the device as measured by a qualitative questionnaire

Find a Location

Who is running the clinical trial?

PICS, Inc.Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,818 Previous Clinical Trials
47,295,097 Total Patients Enrolled
8 Trials studying Insomnia
1,843 Patients Enrolled for Insomnia
Bradford W Applegate, Ph.D.Principal InvestigatorPICS, Inc.

Media Library

Handheld Computer (Self-help Treatment) Clinical Trial Eligibility Overview. Trial Name: NCT00310284 — N/A
Insomnia Research Study Groups:
Insomnia Clinical Trial 2023: Handheld Computer Highlights & Side Effects. Trial Name: NCT00310284 — N/A
Handheld Computer (Self-help Treatment) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00310284 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is eligible for inclusion in this clinical experiment?

"This trial seeks to enroll 200 individuals aged 18-75 years old that suffer from sleep deprivation. Prerequisites for participation include: an average of 30 minutes in latency or wakefulness after nodding off, 6 hours or less per night of slumber, present symptoms for a minimum of half a year and insomnia specific signs manifesting at least 3 days every week."

Answered by AI

Is the enrollment period for this research project still open?

"The clinical trial in question is not currently open to recruitment, as per the data provided on clinicaltrials.gov; it was initially posted January 1st 2006 and last updated March 31st 2006. Nevertheless, there are 229 other studies presently recruiting patients."

Answered by AI

Are those aged 30 or over eligible for participation in this trial?

"As indicated by the requirements for participation, individuals aged 18 to 75 are eligible to be included in this experiment."

Answered by AI
~10 spots leftby Mar 2025