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Device Feasibility and Acceptability to Improve Insomnia in Cancer

Primary Purpose

Cancer, Insomnia Chronic

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VAVA prototype
Sponsored by
Medstar Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Cancer

Eligibility Criteria

18 Years - 39 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • MedStar Washington Hospital CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention arm

Arm Description

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.

Outcomes

Primary Outcome Measures

Feasibility of device use
Number of days that a participant interacted with the VAVA
Acceptability
Score on satisfaction subscale of Usability, Satisfaction, Ease of use (USE) scale

Secondary Outcome Measures

Full Information

First Posted
May 1, 2023
Last Updated
October 4, 2023
Sponsor
Medstar Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05875129
Brief Title
Device Feasibility and Acceptability to Improve Insomnia in Cancer
Official Title
Intervention for Chronic Insufficient Sleep in Young Adult Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 20, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medstar Health Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Insomnia Chronic

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
VAVA prototype
Intervention Description
Cognitive behavioral therapy for insomnia
Primary Outcome Measure Information:
Title
Feasibility of device use
Description
Number of days that a participant interacted with the VAVA
Time Frame
14 days
Title
Acceptability
Description
Score on satisfaction subscale of Usability, Satisfaction, Ease of use (USE) scale
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hunter Groninger, MD
Phone
202-877-7445
Email
hunter.groninger@medstar.net
First Name & Middle Initial & Last Name & Degree
Hunter Groninger, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Device Feasibility and Acceptability to Improve Insomnia in Cancer

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