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Behavioral Intervention

Sleep Restriction Therapy for Insomnia

N/A

Waitlist Available

Led By Jerome A Yesavage, MD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

Study Summary

This trial will compare the efficacy of two treatments, sleep restriction and cognitive therapy, for insomnia in Gulf War Veterans. The hypothesis is that the efficacy of these treatments will depend on the subject's baseline characteristics.

Eligible Conditions

Insomnia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Insomnia Severity Index

Secondary outcome measures

Functional Outcomes of Sleep Questionnaire (FOSQ)

Multidimensional Fatigue Inventory (MFI)

SF 36-Item Health Survey 1.0 (SF-36)

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Sleep Restriction TherapyExperimental Treatment1 Intervention

Sleep Restriction Therapy (SR). The initial Time in Bed (TIB) prescription is calculated on the average total sleep time (TST) reported in the baseline sleep logs. After one week, depending on subject's daily sleep logs and adherence to treatment, the therapist suggests a new TIB prescription. Napping is neither prescribed nor proscribed. However, if subjects find themselves having difficulty staying awake during the day, they are advised to take a brief (15 to 30 minutes) nap to ensure their safety.

Group II: Cognitive TherapyExperimental Treatment1 Intervention

Cognitive Therapy (CT). The CT treatment module is designed to meet three general goals: 1) identify dysfunctional sleep cognitions, 2) challenge their validity, and 3) replace them with more adaptive substitutes. Several specific techniques designed to meet these goals are discussed in materials distributed to subjects. Similar to SR, subjects in CT are provided with information about relevant elements of the science of sleep and healthy sleep practices.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sleep Restriction Therapy

2014

N/A

~210

Cognitive Therapy

2010

Completed Phase 4

~2530

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Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,608 Previous Clinical Trials

3,306,482 Total Patients Enrolled

26 Trials studying Insomnia

4,147 Patients Enrolled for Insomnia

Jerome A Yesavage, MDPrincipal InvestigatorVA Palo Alto Health Care System, Palo Alto, CA

Frequently Asked Questions

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

Are there still openings in this research trial?

"According to the clinicaltrials.gov, this study is no longer actively seeking participants. The last edition of this trial was published on November 21st 2022 and the initial posting date was August 1st 2017. Despite that, there remain 228 other trials currently open for recruitment at present."

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