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Insomnia | A Treatment Study Comparing Two Non-Drug, Self-Help Treatment of Chronic Insomnia.

Insomnia research study

What is the primary objective of this study?

The purpose of this study is to determine whether a handheld computer is superior to a self-help manual for the treatment of chronic primary insomnia.

Who is eligible to participate?

Inclusion Criteria: - sleep less than 6.5 hours per night - at least 30 minutes of sleep onset latency or wakefulness after sleep onset - symptoms present for at least 6 months - must have insomnia symptoms at least 3 days per week Exclusion Criteria: - Body Mass Index greater than 32 - Presence of anxiety disorder - Secondary forms of insomnia - Presence of a substance use disorder - Concurrent treatment for another mental disorder - History of other sleep disorders, including: apnea, restless legs, periodic limb movement disorder, or narcolepsy

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Insomnia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Behavioral:Computerized delivery of cognitive-behavioral treatment of insomnia

Behavioral:Self-help manual to improve insomnia symptoms

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Study Status

Unknown status

Start Date: January 2006

Completed Date:

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Changes in sleep parameters via polysomnography

Secondary Outcome: Changes in depression symptoms as measured by Beck Depression Inventory II

Study sponsors, principal investigator, and references

Principal Investigator: Bradford W Applegate, Ph.D.

Lead Sponsor: PICS, Inc.

Collaborator: National Heart, Lung, and Blood Institute (NHLBI)

More information:https://clinicaltrials.gov/show/NCT00310284

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