Device Feasibility and Acceptability to Improve Insomnia in Cancer

Intervention for Chronic Insufficient Sleep in Young Adult Cancer Survivors

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.

Study Overview

• Status: Completed
• Conditions: Cancer; Insomnia Chronic
• Intervention / Treatment: Device: VAVA prototype

Detailed Description

Sleep is a complex biobehavioral event, impacted by interactions between the individual's physiology as well as their environment. Young adult cancer survivors (YACS; those between 18- 29 years of age) are a growing group of survivors, numbering close to 400,000 in the US. They are among those at highest risk for chronically insufficient sleep due to developmentally normative biological and social factors, compounded by their extensive medical treatment history. Cognitive-behavioral therapy for insomnia (CBT-I) is recommended by the American College of Physicians as gold standard treatment for insomnia disorder and has been successfully adapted for YACS. Fundamental CBT-I strategies can be implemented to change the problematic sleep behaviors that result in insufficient sleep among young adults. However, it is essential that these evidence-based strategies be deployed to be responsive to the specific barriers to sleep for YACS. This feasibility/acceptability study will test the use of an integrated VAVA that offers the opportunity to implement intervention strategies in a way that repeatedly gives YACS the chance to make the right decision with respect to their sleep health in real time.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • Medstar Washington Hospital Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm; 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; Cognitive behavioral therapy for insomnia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Medstar Health Research Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2022
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: May 1, 2023
• First Submitted That Met QC Criteria: May 22, 2023
• First Posted (Actual): May 25, 2023

Study Record Updates

• Last Update Posted (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Neoplasms; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: STUDY00006301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No