CancerNCT05875129
Device Feasibility and Acceptability to Improve Insomnia in Cancer
A study testing VAVA prototype in people with Cancer and Insomnia Chronic, run by Medstar Health Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Cancer, Insomnia Chronic
- What is being tested?
- VAVA prototype
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- acute medical/psychiatric disorder requiring treatment
- developmental or congenital disorder
- life expectancy <12 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: 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.
Read the 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.
- Conditions
- Cancer, Insomnia Chronic
- Being tested
- VAVA prototype
- Medical subject headings
- Neoplasms, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VAVA prototypeDevice
Cognitive behavioral therapy for insomnia
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: VAVA prototype |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of device use
Number of days that a participant interacted with the VAVA
Measured: 14 days
Acceptability
Score on satisfaction subscale of Usability, Satisfaction, Ease of use (USE) scale
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start20 Jul 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05875129
- Sponsor's protocol ID
- STUDY00006301
- Status last verified
- Sep 2025
- First submitted
- 1 May 2023
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 40063947
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention for Chronic Insufficient Sleep in Young Adult Cancer Survivors
- ClinicalTrials.gov ID
- NCT05875129
- Acronym / sponsor ID
- STUDY00006301
- Conditions
- Cancer, Insomnia Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- 20 Jul 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 25 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Device: VAVA prototypeParticipants (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. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- acute medical/psychiatric disorder requiring treatment
- developmental or congenital disorder
- life expectancy <12 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VAVA prototypeCognitive behavioral therapy for insomnia | Device | Intervention arm |
Primary outcome
Feasibility of device use
Time frame: 14 days
Number of days that a participant interacted with the VAVA
Acceptability
Time frame: 14 days
Score on satisfaction subscale of Usability, Satisfaction, Ease of use (USE) scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Derived from this study: PubMed 40063947Groninger 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VAVA prototype in people with Cancer and Insomnia Chronic, run by Medstar Health Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of device use (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05875129, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.