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SleepISLEEPNCT04151251

Inpatient Sleep Loss: Educating and Empowering Patients

A study testing Patient Empowerment and Sleep Kit in people with Sleep, run by University of Chicago at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

While many interventions have targeted hospital staff to improve sleep, few have been successful, and often suffer from limited adherence to staff protocols. Given preliminary data that suggests that empowered patients are more likely to obtain better sleep and have objectively lower noise levels in their rooms, it is… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Sleep
What is being tested?
Patient Empowerment and Sleep Kit
Could I receive a placebo?
No, everyone receives an active treatment
How many people
256 participants
Where
1 siteUnited States
Study dates
8 Jan 2020to 31 Mar 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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Admitted to the general/hospitalist medicine departments
  • Stayed at least one night in hospital since admission

Who cannot join

  • Admitted >72 hours ago
  • Patient has been diagnosed with a sleep disorder such as narcolepsy, insomnia, or sleep apnea
  • Patient was transferred from ICU or outside hospital
  • Patient under strict, droplet, or airborne isolation precautions
  • Unable to ambulate
  • Too confused or incoherent to provide consent
Show all 10Show fewer
  • Patient cannot speak English
  • Pregnancy
  • Residence in a nursing home or assisted living facility
  • Patient was admitted in a hospital within two weeks of current admission

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

Other trials in United States

About this study

Official title: Mentoring Patient-Oriented Research: Sleep & Health During & After Hospital Stay

While many interventions have targeted hospital staff to improve sleep, few have been successful, and often suffer from limited adherence to staff protocols. Given preliminary data that suggests that empowered patients are more likely to obtain better sleep and have objectively lower noise levels in their rooms, it is plausible that partnering directly with patients can mitigate sleep loss and improve health outcomes. Patients will be randomized to receive the I-SLEEP education and empowerment program and test the effectiveness of this program on patient sleep and health outcome in the hospital and post-discharge. The aim of the project is to reduce environmental, healthcare-related, and patient-related factors that disrupt sleep of hospitalized patients by use of patient education and empowerment intervention.

Conditions
Sleep
Being tested
Patient Empowerment, Sleep Kit

What participants receive

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

  • Patient EmpowermentBehavioural

    Group to receive a 5 minute video about typical hospital sleep disruptions and what they can do to prevent them, as well as a brochure outlining the importance of sleep

  • Sleep KitOther

    Patients receive a small pouch that includes an eye mask, ear plugs, and headphones, all to be used to aid in falling/staying asleep

Study groups in NCT04151251
Study groupRoleWhat they receive
Sleep Kit AloneActive comparatorPatients who are not randomized into the I-SLEEP intervention will receive a sleep kit that includes an eye mask, earplugs, and headphones.They will still receive the usual standard of care provided by clinicians which includes measures to reduce unnecessary nighttime disruptions and limiting excessive noise within the hospital setting.
Receives: Other: Sleep Kit
Sleep Kit + EmpowermentExperimentalA short video will be shown on iPads and a brochure will be given that both describe the importance of good sleep and how to facilitate it with good sleep hygiene. The video will show a few reasons why someone might not get optimal sleep while in a hospital, and offer advice to address this from a doctor. The brochure will be kept to no higher than a 6th grade reading level, considered optimal for health education materials. Text will be kept brief and to the point. To account for vision problems, we will use >12-point font \& leave a large portion of each page empty. Visual Aids \& graphics will be employed when possible. All of this is given in addition to the usual standard of care provided by clinicians.
Receives: Behavioral: Patient Empowerment; Other: Sleep Kit

What is being measured

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

  1. Karolinska Sleep Log - Sleep Times

    A self-reported measure of time spent sleeping, time it took to fall asleep, etc.

    Measured: Through stay in the hospital until discharge, usually 2-3 days

Secondary outcomes (6)

  1. Frequency of Sleep Disruptions in the Hospital Setting

    Administered to obtain a subjective view of typical disruptions to sleep such as bed comfort, room temperature, and pain. Items will also assess the disruptions that are caused by healthcare, such as vital signs, medication administration, and lab-work. This survey includes an item on how disruptive noise was to the patient's sleep, broken down into as many sources of hospital noise as possible.

    Measured: Through stay in the hospital until discharge, usually 2-3 days

  2. Patients Who Report Talking to Clinicians About Their Healthcare

    Measure of number of patients who advocate for their sleep by making lifestyle changes, including speaking to their clinicians to reduce nighttime disruptions

    Measured: Through stay in the hospital until discharge, usually 2-3 days

  3. Number of nighttime disruptions to sleep

    Measure of disruptions patients receive between 11 PM and 7 AM, determined by hospital hand sanitizer stations outside doors and electronic health record audits

    Measured: Through stay in the hospital until discharge, usually 2-3 days

  4. Karolinska Sleep Log - Outcomes of Sleep

    Subjective quality of sleep as determined by scales such as "On a scale of 1 to 5, with 5 being the most, how refreshed did you feel upon waking up this morning?"

    Measured: Through stay in the hospital until discharge, usually 2-3 days

  5. Actigraphy - Objective Measure of Sleep Duration

    Actiwatch Spectrum Pros used to determine sleep duration

    Measured: During stay at the hospital, for a week after, and for a week three months after discharge

  6. Actigraphy - Objective Measure of Sleep Quality

    Actiwatch Spectrum Pros used to determine sleep quality

    Measured: During stay at the hospital, for a week after, and for a week three months after discharge

Timeline

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

  1. First posted5 Nov 2019
  2. Study start8 Jan 2020
  3. Primary completion31 Mar 2023
  4. Study completion31 Mar 2023

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
256 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04151251
Sponsor's protocol ID
IRB19-0169
Acronym
ISLEEP
Status last verified
May 2023
First submitted
28 Oct 2019
Last updated
16 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Deidentified data will be available to researchers by request

Publications

  • Arora VM, Machado N, Anderson SL, Desai N, Marsack W, Blossomgame S, Tuvilleja A, Ramos J, Francisco MA, LaFond C, Leung EK, Valencia A, Martin SK, Meltzer DO, Farnan JM, Balachandran J, Knutson KL, Mokhlesi B. Effectiveness of SIESTA on Objective and Subjective Metrics of Nighttime Hospital Sleep Disruptors. J Hosp Med. 2019 Jan;14(1):38-41. doi: 10.12788/jhm.3091.

    PubMed 30667409

  • Adachi M, Staisiunas PG, Knutson KL, Beveridge C, Meltzer DO, Arora VM. Perceived control and sleep in hospitalized older adults: a sound hypothesis? J Hosp Med. 2013 Apr;8(4):184-90. doi: 10.1002/jhm.2027. Epub 2013 Mar 18.

    PubMed 23504939

  • Mason NR, Orlov NM, Anderson S, Byron M, Mozer C, Arora VM. Piloting I-SLEEP: a patient-centered education and empowerment intervention to improve patients' in-hospital sleep. Pilot Feasibility Stud. 2021 Aug 19;7(1):161. doi: 10.1186/s40814-021-00895-z.

    PubMed 34412696

Questions about this trial

What is this clinical trial studying?

A study testing Patient Empowerment and Sleep Kit in people with Sleep, run by University of Chicago 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 2 inclusion and 10 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 16 May 2023. 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?

Karolinska Sleep Log - Sleep Times (time frame: Through stay in the hospital until discharge, usually 2-3 days). 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 NCT04151251, which also lists 3 linked publications.

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 16 May 2023.

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