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Behavioral Intervention

mHealth Technology for Insomnia in Breast Cancer Survivors

N/A
Recruiting
Led By Hannah Arem, PhD
Research Sponsored by Medstar Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has not undergone other behavioral sleep treatment within the prior 12 months
Females; Age 18+
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights

Study Summary

This trial will determine if voice-activated smart speakers can help reduce insomnia symptoms in breast cancer survivors.

Who is the study for?
This trial is for female breast cancer survivors, aged 18 or older, who have finished their main treatments over 3 months ago and are experiencing insomnia. They should not have had other sleep treatments in the past year and must be able to speak English. Those with severe mental health issues, substance abuse history, shift work patterns, or certain untreated sleep disorders cannot join.Check my eligibility
What is being tested?
The study tests a website and smart speaker program designed to help with insomnia using Cognitive Behavioral Therapy for Insomnia (CBT-I) techniques. Participants will be randomly assigned to use these digital tools to see if they improve sleep quality among those who've survived breast cancer.See study design
What are the potential side effects?
Since this trial involves behavioral therapy through digital platforms rather than medication, there are no direct physical side effects expected from participating. However, participants may experience changes in their sleeping patterns as they adjust to the therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I haven't had any sleep treatments in the last year.
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I am a woman aged 18 or older.
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I finished my cancer treatment aimed at curing it more than 3 months ago.
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I have been diagnosed with breast cancer at stage I-III or IV but can still perform daily activities.

Timeline

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 Symptoms
Secondary outcome measures
Sleep efficiency
Sleep onset latency
Total sleep time
+1 more
Other outcome measures
Sleep quality
System usability scale

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Voice-Activated Smart Speaker ProgramExperimental Treatment1 Intervention
Faster Asleep
Group II: WebsiteActive Control1 Intervention
Faster Asleep Website

Find a Location

Who is running the clinical trial?

Medstar Health Research InstituteLead Sponsor
188 Previous Clinical Trials
115,545 Total Patients Enrolled
Media RezUNKNOWN
1 Previous Clinical Trials
300 Total Patients Enrolled
Dana-Farber Cancer InstituteOTHER
1,072 Previous Clinical Trials
340,330 Total Patients Enrolled
6 Trials studying Insomnia
488 Patients Enrolled for Insomnia

Media Library

Faster Asleep Smart Speaker Program (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05233800 — N/A
Insomnia Research Study Groups: Voice-Activated Smart Speaker Program, Website
Insomnia Clinical Trial 2023: Faster Asleep Smart Speaker Program Highlights & Side Effects. Trial Name: NCT05233800 — N/A
Faster Asleep Smart Speaker Program (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05233800 — N/A

Frequently Asked Questions

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

What is the maximum capacity of participants for this research endeavor?

"Affirmative. According to clinicaltrials.gov, the study, which was first posted on April 5th 2022 is actively searching for 76 participants at a single location. It has also been recently updated on April 18th 2022."

Answered by AI

Is this research endeavor accommodating new participants?

"Clinicaltrials.gov confirms that this clinical trial has been actively recruiting since it was first posted on April 5th 2022 and last updated on April 18th of the same year."

Answered by AI
~26 spots leftby Mar 2025