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CBT for Insomnia

N/A
Waitlist Available
Led By Noam Alperin
Research Sponsored by University of Miami
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 year 2
Awards & highlights

Study Summary

This trial is testing whether improving sleep quality can help slow down brain aging.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~year 2
This trial's timeline: 3 weeks for screening, Varies for treatment, and year 2 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of brain tissue volume loss in specific brain regions
Secondary outcome measures
Cognitive Performance

Side effects data

From 2018 Phase 4 trial • 95 Patients • NCT01041274
18%
Weight increase
10%
Tachycardia
6%
Psychiatric Hospitalization
6%
Hypertension
6%
Loss of libido
4%
Concentration impaired
4%
Appetite increase
4%
Memory impaired
4%
Rash
4%
Restlessness
4%
Amenorrhea
2%
Sleep disturbed
2%
Anorgasmia
2%
Blurred vision
2%
Dizziness upon standing
2%
Drug abuse
2%
Akathisia
2%
Drooling
2%
Appetite decrease
2%
Drug-related hospitalization
2%
Apathy
2%
Cellulitis
2%
Hot flashes
2%
Medical Hospitalization
2%
Fatigue
2%
Hiccup
2%
Hit by a motorcycle
2%
Hurt when riding a bike
2%
Mental activity decreased
2%
Muscle twitch
2%
Sleeplessness
2%
Pneumonia
2%
Nightmares
2%
Teeth grating
2%
Incarceration
2%
Sensory hallucinations
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Citalopram

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Cognitive Behavioral Therapy (CBT) GroupExperimental Treatment1 Intervention
Participants will receive CBT intervention bi-weekly for total of six (6) sessions.
Group II: Control GroupActive Control1 Intervention
Participants will not receive any intervention as part of the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Behavioral Therapy (CBT)
2008
Completed Phase 4
~3620

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
899 Previous Clinical Trials
409,632 Total Patients Enrolled
2 Trials studying Insomnia
90 Patients Enrolled for Insomnia
Florida Department of HealthOTHER_GOV
28 Previous Clinical Trials
12,903 Total Patients Enrolled
Noam AlperinPrincipal Investigator - University of Miami
University of Miami

Media Library

Cognitive Behavioral Therapy (CBT) Clinical Trial Eligibility Overview. Trial Name: NCT04583033 — N/A
Cognitive Behavioral Therapy (CBT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04583033 — N/A
Insomnia Research Study Groups: Cognitive Behavioral Therapy (CBT) Group, Control Group
Insomnia Clinical Trial 2023: Cognitive Behavioral Therapy (CBT) Highlights & Side Effects. Trial Name: NCT04583033 — N/A

Frequently Asked Questions

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

Does the protocol for this research study permit individuals aged 40 and above to partake?

"According to the study's eligibility requirements, patients must be between 55 and 70 years old in order to participate."

Answered by AI

Is there availability for participants in this investigation?

"Affirmative. The information found on clinicaltrials.gov shows that this experiment is still recruiting participants, with the initial posting being made September 28th 2021 and last updated on September 28th 2022. 100 research subjects are needed at a single medical centre for participation in the study."

Answered by AI

What is the total number of participants being recruited for this experiment?

"Affirmative. Clinicaltrials.gov details that this research study, posted on September 28th 2021, is still recruiting participants from a single site with the goal of enrolling 100 patients."

Answered by AI

Is there a way I can join this clinical experiment?

"This research seeks a hundred participants aged 55 to 70 who suffer from impaired slumber. Eligible subjects must possess the capacity and willingness to consent, while being fluent in English. Additionally, they should be of sound cognition with demonstrable issues that lead to poor sleep quality as evaluated by self-reporting methods."

Answered by AI

Who else is applying?

What site did they apply to?
University of Miami
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Sleep Well for Healthy Brain
Noam Alperin 2021. "Sleep Well for Healthy Brain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04583033.
~29 spots leftby Apr 2025
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