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Behavioural Intervention

Subjects treated with Cognitive Behavior Treatment for Insomnia (CBT-I) with Trazodone for Insomnia

Q: In how many different medical centers can patients access this clinical trial?

The recruitment for this trial includes sites such as National Jewish Health in Denver, the University of Pittsburgh in Pittsburgh, and Université Laval in Quebec. Additionally, there are 4 other locations involved in patient enrollment.

Q: Are there any ongoing efforts to enroll patients in this research study?

As per information from clinicaltrials.gov, the current trial is not open for recruitment. Originally shared on March 1st, 2024 and last revised on February 26th, 2024. Despite this trial being inactive in terms of recruitment, there are currently 1032 other trials seeking participants.

Q: What are the anticipated results that researchers hope to achieve through this experimental investigation?

This study aims to achieve a state of remission from <a href="https://www.withpower.com/clinical-trials/insomnia">insomnia</a> symptoms within 6 months after the conclusion of CBT-I or RCT treatment, as evaluated over a 9-week duration. Additional endpoints include Actigraphy Total <a href="https://www.withpower.com/clinical-trials/sleep">Sleep</a> Time (TST) post-RCT, reflecting minutes asleep during home monitoring following RCT; Home Blood Pressure (HBP) Morning Systolic Blood Pressure (SBP), representing morning SBP readings taken at home over a week-long period; and Evening Cortisol levels half a year after completing CBT-I or RCT Treatment, assessed through saliva samples.

Phase < 1

Recruiting

Led By Alexandros Vgontzas, MD

Research Sponsored by Milton S. Hershey Medical Center

Eligibility Criteria Checklist

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

Must have

Age 18 or older

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 35 weeks

Awards & highlights

Study Summary

This trial aims to compare how individuals with insomnia and short sleep duration differ from those with normal sleep duration in terms of health risks and response to treatment. The study will investigate the effectiveness of two common insomnia

Who is the study for?

This trial is for adults with chronic insomnia, particularly those who sleep less than normal (ISS) or have a normal sleep duration (INS), and also have high blood pressure. Participants should not be currently using other treatments for insomnia.Check my eligibility

What is being tested?

The study tests Cognitive Behavioral Therapy for Insomnia (CBT-I), which is a non-drug treatment focusing on changing sleep habits, versus Trazodone, a low-dose medication that helps with sleep without forming habits. The effectiveness of these treatments will be compared.See study design

What are the potential side effects?

Possible side effects from Trazodone include drowsiness during the day, dizziness, constipation, blurred vision, and dry mouth. CBT-I generally does not cause physical side effects but may require time commitment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 35 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~35 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 35 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

Remission of insomnia symptoms 6 months following completion of CBT-I Or RCT Treatment

Remission of insomnia symptoms following Cognitive Behavioral Therapy for Insomnia (CBT-I)

Remission of insomnia symptoms following trazodone/placebo Randomized Controlled Trial (RCT)

Secondary outcome measures

Actigraphy Sleep efficiency following Cognitive Behavioral Therapy for Insomnia (CBT-I)

Actigraphy Total Sleep Time (TST) following RCT

Evening Cortisol levels 6 months following completion of CBT-I or RCT Treatment

+8 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Subjects treated with Cognitive Behavior Treatment for Insomnia (CBT-I) with TrazodoneActive Control2 Interventions

Subjects with insomnia treated with Cognitive Behavior Treatment for Insomnia (CBT-I) for 8 weeks, then non-remitting subjects received trazodone for 8 weeks.

Group II: Subjects treated with Cognitive Behavior Treatment for Insomnia (CBT-I) with placeboPlacebo Group2 Interventions

Subjects with insomnia treated with Cognitive Behavior Treatment for Insomnia (CBT-I) for 8 weeks, then non-remitting subjects received placebo for 8 weeks.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,840 Previous Clinical Trials

47,851,524 Total Patients Enrolled

9 Trials studying Insomnia

5,123 Patients Enrolled for Insomnia

Milton S. Hershey Medical CenterLead Sponsor

495 Previous Clinical Trials

2,798,274 Total Patients Enrolled

3 Trials studying Insomnia

35 Patients Enrolled for Insomnia

Alexandros Vgontzas, MDPrincipal InvestigatorProfessor, Psychiatry

Frequently Asked Questions

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

In how many different medical centers can patients access this clinical trial?

"The recruitment for this trial includes sites such as National Jewish Health in Denver, the University of Pittsburgh in Pittsburgh, and Université Laval in Quebec. Additionally, there are 4 other locations involved in patient enrollment."

Answered by AI

Are there any ongoing efforts to enroll patients in this research study?

"As per information from clinicaltrials.gov, the current trial is not open for recruitment. Originally shared on March 1st, 2024 and last revised on February 26th, 2024. Despite this trial being inactive in terms of recruitment, there are currently 1032 other trials seeking participants."

Answered by AI

What are the anticipated results that researchers hope to achieve through this experimental investigation?

"This study aims to achieve a state of remission from insomnia symptoms within 6 months after the conclusion of CBT-I or RCT treatment, as evaluated over a 9-week duration. Additional endpoints include Actigraphy Total Sleep Time (TST) post-RCT, reflecting minutes asleep during home monitoring following RCT; Home Blood Pressure (HBP) Morning Systolic Blood Pressure (SBP), representing morning SBP readings taken at home over a week-long period; and Evening Cortisol levels half a year after completing CBT-I or RCT Treatment, assessed through saliva samples."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia

Alexandros Vgontzas 2024. "Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06281756.

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