Device Feasibility and Acceptability to Improve Insomnia in Cancer

NCT05875129 | Completed

• 1 other identifier: STUDY00006301
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Sleep disruption is common among young adult cancer survivors for a variety of reasons. Cognitive behavioral therapy for insomnia (CBT-I) has been shown to improve chronic sleep disorders. This project will test the feasibility and acceptability of a new voice-activated virtual assistant (VAVA) device to deliver CBT-I to improve sleep among young adult cancer survivors with chronic sleep disorders.

Conditions

Cancer; Insomnia Chronic

Outcome Measures

Primary Outcomes (2)

• Feasibility of device use

  Number of days that a participant interacted with the VAVA

  14 days

• Acceptability

  Score on satisfaction subscale of Usability, Satisfaction, Ease of use (USE) scale

  14 days

Study Arms (1)

Intervention arm

EXPERIMENTAL

Participants (N=15) will will be provided with the VAVA prototype along with installation instructions to embed the VAVA within their homes. We provide them with a smart speaker running our intervention, a smart lamp, and a new router. They will be asked to trial the VAVA for a period of 2 weeks, a duration consistent with the primary stage of CBT-I treatment.

Device: VAVA prototype

Interventions

VAVA prototype DEVICE

Cognitive behavioral therapy for insomnia

Intervention arm

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• age between 18 and 29 years old
• history of cancer (any type, any stage)
• chronic sleep loss as evidence by self-report of receiving less sleep than recommended for their age by the National Sleep Foundation for \>/= 3 months
• must have an internet router in their primary home that they have access to (can add a second router to for the system to work)

You may not qualify if:

• acute medical/psychiatric disorder requiring treatment
• developmental or congenital disorder
• life expectancy \<12 months.

Sponsors & Collaborators

• Medstar Health Research Institute: lead

Study Sites (1)

MedStar Washington Hospital Center

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

Location

Related Publications (1)

• Groninger H, Arem H, Ayangma L, Gong L, Zhou E, Greenberg D. Development of a Voice-Activated Virtual Assistant to Improve Insomnia Among Young Adult Cancer Survivors: Mixed Methods Feasibility and Acceptability Study. JMIR Form Res. 2025 Mar 10;9:e64869. doi: 10.2196/64869.

  PMID: 40063947 DERIVED

MeSH Terms

Conditions

Neoplasms; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Through the VAVA (an Amazon Alexa provided as part of the study), participants will verbally provide information about their sleep habits and sleep quality and receive suggestions about how to improve their sleep. Via the VAVA, these interactions will happen through the prototype software More SHEEP (MediaRez LLC). The recommendations provided by the More SHEEP software will be tailored to the individual participant, based on the data provided verbally by each participant. The participant will be asked to engage with the VAVA prototype daily for a 2-week period.

Study Record Dates

• First Submitted: May 1, 2023
• First Posted: May 25, 2023
• Study Start: July 20, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)