NCT05233800

Brief Summary

The aim of this study is to determine the impact of the voice-activated smart speaker CBT-I components on insomnia symptoms among breast cancer survivors using a randomized clinical trial.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 10, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

April 5, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

January 24, 2025

Completed
Last Updated

January 24, 2025

Status Verified

December 1, 2024

Enrollment Period

1.7 years

First QC Date

January 20, 2022

Results QC Date

October 2, 2024

Last Update Submit

December 18, 2024

Conditions

Breast Cancer SurvivorInsomnia

Keywords

Breast Cancer SurvivorInsomniamHealthDigital HealthCognitive Behavioral Therapy for Insomnia (CBT-I)

Outcome Measures

Primary Outcomes (1)

  • Insomnia Symptoms

    Data will be collected on the Insomnia Severity Index (ISI) total score pre- and post-intervention as our primary outcome. The ISI is a seven-item questionnaire with response categories from 0-4 (total score 0-28) asking about sleep patterns and specifically characterizing insomnia over the two weeks prior. The ISI defines 'no clinically significant' insomnia as a score of 0-7, 'sub-threshold' insomnia as a score of 8-14, 'moderate severity clinical' insomnia' a scores of 15-21, and 'severe clinical' insomnia as a score of 22-28. Clinically relevant target for success is to achieve sub-threshold or better scores (≤14) among \>80% of the intervention participants

    6 weeks

Secondary Outcomes (4)

  • Six Week Change in Sleep Efficiency

    6 weeks

  • Six Week Change in Wake After Sleep Onset

    6 weeks

  • Six Week Change in Sleep Onset Latency

    6 weeks

  • Six Week Change in Total Sleep Time

    6 weeks

Other Outcomes (2)

  • System Usability Scale

    6 weeks

  • End of Study Self-reported Sleep Quality

    6 weeks

Study Arms (2)

Voice-Activated Smart Speaker Program

EXPERIMENTAL

Faster Asleep

Behavioral: Faster Asleep Smart Speaker Program

Website

ACTIVE COMPARATOR

Faster Asleep Website

Behavioral: Faster Asleep Website

Interventions

Faster Asleep Smart Speaker ProgramBEHAVIORAL

Participants will receive a smart speaker device with a pre-loaded Faster Asleep program. Participants will be asked to engage with the program daily, either using the voice-activated speakers or an accompanying smart-phone app. The study duration is six-weeks and is completed individually using fully automated interaction to deliver components of cognitive behavioral therapy for insomnia.

Voice-Activated Smart Speaker Program
Faster Asleep WebsiteBEHAVIORAL

Controls will have access to a website with information about CBT-I and breast cancer survivorship and will be told to engage with the website as desired. The content will be drawn from the education script that is programmed into the phone app accompanying the smart speaker program.

Website

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Willingness to maintain a consistent dosing pattern if currently taking sleep medications or using cannabis for sleep
  • Females; Age 18+
  • Self-reported or documented diagnosis of breast cancer stage I-III or stage IV ECOG 0-1
  • Completed curative treatment (surgery, radiation, chemotherapy) \> 3 months prior to enrollment \[ongoing adjuvant therapy permitted\]
  • Has not undergone other behavioral sleep treatment within the prior 12 months
  • Score greater than or equal to 8 on the Insomnia Severity Index
  • Able to understand and speak English

You may not qualify if:

  • Diagnosed, untreated obstructive sleep apnea syndrome, narcolepsy, restless leg syndrome, periodic limb movement disorder, delayed sleep phase syndrome, central apnea
  • Shift-work in the prior three months or anticipated during the study time
  • Planned regular travel out of time zone (\>1 hour) during the study period.
  • Currently or planning to become pregnant during the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Related Publications (4)

  • Cai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2.

    PMID: 41170811DERIVED

  • Starling CM, Greenberg D, Lewin D, Shaw C, Zhou ES, Lieberman D, Chou J, Arem H. Voice-Activated Cognitive Behavioral Therapy for Insomnia: A Randomized Clinical Trial. JAMA Netw Open. 2024 Sep 3;7(9):e2435011. doi: 10.1001/jamanetworkopen.2024.35011.

    PMID: 39316400DERIVED

  • Lewin D, Starling CM, Zhou ES, Greenberg D, Shaw C, Arem H. A novel voice interactive sleep log: concurrent validity with actigraphy and sleep diaries. J Clin Sleep Med. 2024 Feb 1;20(2):309-312. doi: 10.5664/jcsm.10878.

    PMID: 37869974DERIVED

  • Starling CM, Greenberg D, Zhou E, Lewin D, Morrow AS, Lieberman D, Shaw C, Arem H. Testing delivery of components of cognitive behavioral therapy for insomnia to breast cancer survivors by smart speaker: a study protocol. BMC Med Inform Decis Mak. 2022 Jun 21;22(1):163. doi: 10.1186/s12911-022-01902-w.

    PMID: 35729605DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Results Point of Contact

Title
Hannah Arem, Scientific Director, Implementation Science
Organization
MedStar Health Research Institute
hannah.arem@medstar.net
2028932430

Study Officials

  • Hannah Arem, PhD

    Medstar Health Research Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Scientific Director, Implementation Science

Study Record Dates

First Submitted

January 20, 2022

First Posted

February 10, 2022

Study Start

April 5, 2022

Primary Completion

December 15, 2023

Study Completion

December 15, 2023

Last Updated

January 24, 2025

Results First Posted

January 24, 2025

Record last verified: 2024-12

Locations

US(1)