Clincosm LogoSign in Get a demo

Device Feasibility and Acceptability to Improve Insomnia in Cancer

Sponsor
Medstar Health Research Institute (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05875129
Collaborator
(none)
15
Enrollment
1
Location
1
Arm
3
Anticipated Duration (Months)
5.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: VAVA prototype
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
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.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.
Masking:
None (Open Label)
Primary Purpose:
Device Feasibility
Official Title:
Intervention for Chronic Insufficient Sleep in Young Adult Cancer Survivors
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Aug 30, 2023
Anticipated Study Completion Date :
Aug 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Feasibility of device use [14 days]

    Number of days that a participant interacted with the VAVA

  2. Acceptability [14 days]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 29 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • age between 18 and 29 years old

  • history of cancer (any type, any stage) with at least 3 months either in remission or off anti-cancer treatment

  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 MedStar Washington Hospital Center Washington District of Columbia United States 20010

Sponsors and Collaborators

  • Medstar Health Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Medstar Health Research Institute
ClinicalTrials.gov Identifier:
NCT05875129
Other Study ID Numbers:
  • STUDY00006301
First Posted:
May 25, 2023
Last Update Posted:
May 25, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders

Study Results

No Results Posted as of May 25, 2023