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OpenTrials
Completed

NCT Number: NCT05875129

Device Feasibility and Acceptability to Improve Insomnia in Cancer

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.

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Key information

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MedStar Washington Hospital Center

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VAVA prototype

Device

Cognitive behavioral therapy for insomnia

Primary outcomes

  1. Feasibility of device use

    Time frame: 14 days

    Number of days that a participant interacted with the VAVA

  2. Acceptability

    Time frame: 14 days

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

Sponsors and collaborators

Lead sponsor

Medstar Health Research Institute

Other

Registry information

Official study title

Intervention for Chronic Insufficient Sleep in Young Adult Cancer Survivors

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 25, 2023
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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