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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
Self-reported or documented diagnosis of breast cancer stage I-III or stage IV ECOG 0-1
Be older than 18 years old
Must not have
Planned regular travel out of time zone (>1 hour) during the study period.
Diagnosed, untreated obstructive sleep apnea syndrome, narcolepsy, restless leg syndrome, periodic limb movement disorder, delayed sleep phase syndrome, central apnea
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
No Placebo-Only Group

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.
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.
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
Select...
I have been diagnosed with breast cancer at stage I-III or IV but can still perform daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I plan to travel out of my time zone for more than an hour during the study.
Select...
I have been diagnosed with a sleep disorder but haven't received treatment.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Insomnia Symptoms
Secondary study objectives
Sleep efficiency
Sleep onset latency
Total sleep time
+1 more
Other study objectives
Sleep quality
System usability scale

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
195 Previous Clinical Trials
183,083 Total Patients Enrolled
6 Trials studying Breast Cancer
1,205 Patients Enrolled for Breast Cancer
Media RezUNKNOWN
1 Previous Clinical Trials
300 Total Patients Enrolled
Dana-Farber Cancer InstituteOTHER
1,107 Previous Clinical Trials
357,061 Total Patients Enrolled
145 Trials studying Breast Cancer
20,212 Patients Enrolled for Breast Cancer

Media Library

Faster Asleep Smart Speaker Program (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05233800 — N/A
Breast Cancer Research Study Groups: Voice-Activated Smart Speaker Program, Website
Breast Cancer 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
~21 spots leftby Nov 2025
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