SleepPhase 2/3NCT05456360

Implementation of Digital Vital Sign Monitoring to Decrease Sleep Interruption and Enhance Recovery in Phase II of the PROmoting Sleep, Patient Engagement and Recovery (PROSPER) Project

A Phase 2/3 study testing ViSi Mobile device and Sleep enhancement intervention in people with Sleep, run by M.D. Anderson Cancer Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Sleep
What is being tested?: ViSi Mobile device and Sleep enhancement intervention
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 89 participants
Where: 1 siteUnited States
Study dates: 1 Mar 2023to 30 Oct 2023
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult patients (> 18 years of age), english speaking, able to complete consent and survey materials.
Patients must be admitted to the hospital for at least 3 nights.
Patient's using pharmacological sleeping aides will be included in the study as this will help us understand if the intervention will also help patients with pre-exisitng sleep disturbances.

Who cannot join

Vulnerable populations (pregnancy, incarcerated, history of delirium, suicidal ideation, ischemic stroke with measurable neurologic deficit, cerebral palsy, seizures), primary brain tumor/metastases patients.
Patients concurrently enrolled in contact isolation with SARS-CoV2 will be excluded.
Lastly, hospice or hospice-bound patients will also be excluded.
Any patient can remove themselves from the study at any point.

Trial locations and contacts

1 site in 1 country.

United States1 site

MD Anderson Cancer Center
Houston, Texas, 77030

Other trials in United States

About this study

This phase II/III trial examines how a sleep enhancement intervention, including the use of wearable digital vital sign monitoring device (ViSi), affects the quality of life of cancer patients receiving acute care. Sleep enchancement interventions may improve the quality of life of patients with cancer due to fewer interruptions at night during hospital stays.

Read the detailed description

Objective:

Primary Objective:

1). Investigate the impact of our sleep enhancement intervention, that entails a wearable digital vital sign monitoring device, on variation in the quality of life of acute care cancer patients

Secondary Objectives:

. Assess the impact of our sleep enhancement intervention on acute care utilization e.g. length of stay, 30-day readmissions
. Assess the implementation and feasibility of wearable digital vital signs capture in an inpatient oncologic setting using validated instruments such as system usability scale (SUS) and Weiner implementation outcomes (AIM, FIM, IAM).
. Assess the impact, via validated survey instruments, of our sleep enhancement intervention on patient mood, patient activation and satisfaction with inpatient stay experience.

Conditions: Sleep
Being tested: ViSi Mobile device, Sleep enhancement intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ViSi Mobile deviceDevice
Participants will wear the device on your wrist like a watch, and it will continuously (non-stop) monitor your pulse, blood pressure, temperature, breathing rate, heart rate, and pulse rate
Sleep enhancement interventionDrug
Participants will receive a medication administration will be limited to before bedtime.

Study groups in NCT05456360
Study group	Role	What they receive
Intervention group	Other	Participants will receive sleep enhancement intervention and will wear the ViSi Mobile device. Receives: Device: ViSi Mobile device
Control group	Other	Participants will receive sleep enhancement intervention only. Participants in the control group will not wear the ViSi Mobile device. Receives: Drug: Sleep enhancement intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Quality of Life Questionnaires (EuroQol Group EQ-5D)
Score Scales (0-100) 0-worst health/100 best health
Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 202330 Oct 2023

First posted13 Jul 2022
Study start1 Mar 2023
Primary completion30 Oct 2023
Study completion30 Oct 2023

Why it stopped: Poor accrual and poor patient engagement with survey completion

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SleepStudies of the same condition, open and under way.
More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
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 2/3
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 89 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05456360
Sponsor's protocol ID: 2022-0190
Other IDs: NCI-2022-05712
Status last verified: Nov 2024
First submitted: 7 Jul 2022
Last updated: 18 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Implementation of Digital Vital Sign Monitoring to Decrease Sleep Interruption and Enhance Recovery in Phase II of the PROmoting Sleep, Patient Engagement and Recovery (PROSPER) Project
ClinicalTrials.gov ID: NCT05456360
Acronym / sponsor ID: 2022-0190
Conditions: Sleep
Phase: Phase 2/3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Poor accrual and poor patient engagement with survey completion
Enrolment: 89 participants (actual)
Lead sponsor: M.D. Anderson Cancer CenterUniversity, hospital or other
Study start: 1 Mar 2023 (actual)
Primary completion: 30 Oct 2023 (actual)
Study completion: 30 Oct 2023 (actual)
First posted: 13 Jul 2022 (actual)
Results: Posted 18 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Objective:

Primary Objective:

1). Investigate the impact of our sleep enhancement intervention, that entails a wearable digital vital sign monitoring device, on variation in the quality of life of acute care cancer patients

Secondary Objectives:

. Assess the impact of our sleep enhancement intervention on acute care utilization e.g. length of stay, 30-day readmissions
. Assess the implementation and feasibility of wearable digital vital signs capture in an inpatient oncologic setting using validated instruments such as system usability scale (SUS) and Weiner implementation outcomes (AIM, FIM, IAM).
. Assess the impact, via validated survey instruments, of our sleep enhancement intervention on patient mood, patient activation and satisfaction with inpatient stay experience.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Intervention group	Other	Device: ViSi Mobile deviceParticipants will receive sleep enhancement intervention and will wear the ViSi Mobile device.
Control group	Other	Drug: Sleep enhancement interventionParticipants will receive sleep enhancement intervention only. Participants in the control group will not wear the ViSi Mobile device.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Adult patients (> 18 years of age), english speaking, able to complete consent and survey materials.
Patients must be admitted to the hospital for at least 3 nights.
Patient's using pharmacological sleeping aides will be included in the study as this will help us understand if the intervention will also help patients with pre-exisitng sleep disturbances.

Key exclusion criteria (4 listed)

Vulnerable populations (pregnancy, incarcerated, history of delirium, suicidal ideation, ischemic stroke with measurable neurologic deficit, cerebral palsy, seizures), primary brain tumor/metastases patients.
Patients concurrently enrolled in contact isolation with SARS-CoV2 will be excluded.
Lastly, hospice or hospice-bound patients will also be excluded.
Any patient can remove themselves from the study at any point.

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
ViSi Mobile deviceParticipants will wear the device on your wrist like a watch, and it will continuously (non-stop) monitor your pulse, blood pressure, temperature, breathing rate, heart rate, and pulse rate	Device	Intervention group
Sleep enhancement interventionParticipants will receive a medication administration will be limited to before bedtime.	Drug	Control group

Primary outcome

Quality of Life Questionnaires (EuroQol Group EQ-5D)
Time frame: through study completion, an average of 1 year
Score Scales (0-100) 0-worst health/100 best health

Results and safety

Results posted to the registry on 18 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard of Care	52	16
Intervention: Passive Vital Signs Monitoring	37	9

Primary outcome: Quality of Life Questionnaires (EuroQol Group EQ-5D)

Time frame: through study completion, an average of 1 year

Population analysed: Based on the feedback from the team it was unrealistic to complete the protocol in the estimated period due to lack of patient interest and engagement, data was not collected.

Adverse events

Time frame: Events were monitored during patients' admission. Admission Time average was 3.5 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard of Care	0 of 52 (0%)	0 of 52 (0%)	0 of 52
Intervention: Passive Vital Signs Monitoring	0 of 37 (0%)	0 of 37 (0%)	0 of 37

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
MD Anderson Cancer CenterLink provided by the sponsor.

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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.

Vijaya Gottumukkala, MD principal investigator

M.D. Anderson Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing ViSi Mobile device and Sleep enhancement intervention in people with Sleep, run by M.D. Anderson Cancer Center 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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 18 Dec 2024. 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Quality of Life Questionnaires (EuroQol Group EQ-5D) (time frame: through study completion, an average of 1 year). 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 NCT05456360.

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 18 Dec 2024.