Sleep DisturbanceEarly Phase 1NCT03837249
Self-Management of Sleep Among Older Adults
A Early Phase 1 study testing Personal Sleep Monitoring in people with Sleep Disturbance, run by University of Massachusetts, Amherst at 1 site in United States.
Trial summary
The purpose of this study is to test the feasibility of older persons use of a personal sleep monitoring device(PSMD)to improve self-management of sleep. Disrupted sleep occurs in up to 50% of persons over the age of 65 with chronic health conditions. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Disturbance
- What is being tested?
- Personal Sleep Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2019to 30 Jan 2020
- Phase
- Early Phase 1
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 65 years or older
- Self-report difficulty sleeping
- Willingness to wear the PSMD for four weeks
- Cognitive abilities (Mini Cog of 5 or above).
Who cannot join
- Under the age of 65
- Presence of known sleep disorders
- Severe cognitive or neurosensory impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts
Amherst, Massachusetts, 01003
About this study
Official title: Self-Management of Sleep Among Older Adults Using Personal Monitoring: A Feasibility Study
The purpose of this study is to test the feasibility of older persons use of a personal sleep monitoring device(PSMD)to improve self-management of sleep. Disrupted sleep occurs in up to 50% of persons over the age of 65 with chronic health conditions. Impaired sleep negatively influences subjective and objective health outcomes.To improve their sleep, older adults with chronic health conditions could benefit from objective information, available through personal health monitoring devices, about their current and changing sleep patterns. Based on this information, sleep self-management interventions can be individualized and shared, and associations between sleep and health changes may be better managed.
- Conditions
- Sleep Disturbance
- Being tested
- Personal Sleep Monitoring
- Keywords
- Older People, Sleep Disturbance, Self-Monitoring, Self-Management, Social Support, Wrist-worn Actigraphy
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personal Sleep MonitoringDevice
Also called Personal Sleep Monitor
Wearable Sleep Self-Monitoring Device (Actigraphy)
| Study group | Role | What they receive |
|---|---|---|
| Passive Personal Sleep Monitoring | Placebo comparator | Wears personal sleep monitor but does not actively self-monitor (will have access to the sleep data and self-monitoring after 4 weeks). Receives: Device: Personal Sleep Monitoring |
| Individual Personal Sleep Monitoring | Active comparator | Wears personal sleep monitor and actively self-monitoring sleep and using data to self-manage sleep. Receives: Device: Personal Sleep Monitoring |
| Socially Supported Sleep Monitoring | Active comparator | Wears a personal sleep monitor, actively self-monitoring using sleep data to self-manage sleep and shares data for supportive self-management. Receives: Device: Personal Sleep Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of A Personal Sleep Monitoring Device (PSMD)
Demonstrates use of Personal Sleep Self-Monitor through data downloads and self-report
Measured: up to 4 weeks
Changes in Sleep
Demonstrated sleep changes indicated by change in BRCS NINR PROMIS SF V1 Sleep Disturbance Scale 6a (a 6 item, 5 point likert scale with higher scores reflecting more sleep disturbance and lower scores less.
Measured: Week 1 and Week 4
Changes in Health
Demonstrated health changes indicated by change in BRCS NINR PROMIS Global Health Short Form Scale 10a (10 item, 5 point likert scale) with higher scores reflecting better health (3 items reverse scoring)
Measured: Week 1 and Week 4
Secondary outcomes (1)
Usability of PSMD
Demonstrated through adapted System Usability Scale Scores (10 items, 5 point likert scale) with high agreement demonstrating higher levels of satisfaction using the device
Measured: Week 2 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start4 Feb 2019
- Primary completion30 Aug 2019
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisturbanceStudies 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
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparative control - 3 group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Amherst
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raeann G LeBlanc, University of Massachusetts, Amherst
- Investigators
- Raeann G LeBlanc, PhD, DNP, Principal investigator, University of Massachusetts, Amherst
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03837249
- Sponsor's protocol ID
- 2018-5225
- Status last verified
- Feb 2020
- First submitted
- 24 Jan 2019
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD data will be shared de-identified as a GUID with the cdRNS data base.
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Management of Sleep Among Older Adults Using Personal Monitoring: A Feasibility Study
- ClinicalTrials.gov ID
- NCT03837249
- Acronym / sponsor ID
- 2018-5225
- Conditions
- Sleep Disturbance
- Keywords
- Older People, Sleep Disturbance, Self-Monitoring, Self-Management, Social Support, Wrist-worn Actigraphy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of Massachusetts, AmherstUniversity, hospital or other
- Study start
- 4 Feb 2019 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 12 Feb 2019 (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.
The purpose of this study is to test the feasibility of older persons use of a personal sleep monitoring device(PSMD)to improve self-management of sleep. Disrupted sleep occurs in up to 50% of persons over the age of 65 with chronic health conditions. Impaired sleep negatively influences subjective and objective health outcomes.To improve their sleep, older adults with chronic health conditions could benefit from objective information, available through personal health monitoring devices, about their current and changing sleep patterns. Based on this information, sleep self-management interventions can be individualized and shared, and associations between sleep and health changes may be better managed.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Comparative control - 3 group
| Arm | Type | Receives |
|---|---|---|
| Passive Personal Sleep Monitoring | Placebo comparator | Device: Personal Sleep MonitoringWears personal sleep monitor but does not actively self-monitor (will have access to the sleep data and self-monitoring after 4 weeks). |
| Individual Personal Sleep Monitoring | Active comparator | Device: Personal Sleep MonitoringWears personal sleep monitor and actively self-monitoring sleep and using data to self-manage sleep. |
| Socially Supported Sleep Monitoring | Active comparator | Device: Personal Sleep MonitoringWears a personal sleep monitor, actively self-monitoring using sleep data to self-manage sleep and shares data for supportive self-management. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 65 years or older
- Self-report difficulty sleeping
- Willingness to wear the PSMD for four weeks
- Cognitive abilities (Mini Cog of 5 or above).
Key exclusion criteria (3 listed)
- Under the age of 65
- Presence of known sleep disorders
- Severe cognitive or neurosensory impairment
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 |
|---|---|---|
| Personal Sleep MonitoringAlso: Personal Sleep MonitorWearable Sleep Self-Monitoring Device (Actigraphy) | Device | Individual Personal Sleep Monitoring, Passive Personal Sleep Monitoring, Socially Supported Sleep Monitoring |
Primary outcome
Use of A Personal Sleep Monitoring Device (PSMD)
Time frame: up to 4 weeks
Demonstrates use of Personal Sleep Self-Monitor through data downloads and self-report
Changes in Sleep
Time frame: Week 1 and Week 4
Demonstrated sleep changes indicated by change in BRCS NINR PROMIS SF V1 Sleep Disturbance Scale 6a (a 6 item, 5 point likert scale with higher scores reflecting more sleep disturbance and lower scores less.
Changes in Health
Time frame: Week 1 and Week 4
Demonstrated health changes indicated by change in BRCS NINR PROMIS Global Health Short Form Scale 10a (10 item, 5 point likert scale) with higher scores reflecting better health (3 items reverse scoring)
1 secondary outcome
Usability of PSMD
Time frame: Week 2 and 4
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 26 Feb 2020.
- Individual participant dataSharing planned: No. IPD data will be shared de-identified as a GUID with the cdRNS data base.
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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.
Raeann G LeBlanc, PhD, DNP principal investigator
University of Massachusetts, Amherst
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Personal Sleep Monitoring in people with Sleep Disturbance, run by University of Massachusetts, Amherst 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 26 Feb 2020. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Use of A Personal Sleep Monitoring Device (PSMD) (time frame: up to 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Feb 2020.