SleepI_SLEEPNCT06094699
Improving Sleep in the Neurology In-Patient Population
A study testing Sleep friendly order set and Patient sleep menu in people with Sleep, run by University of Pennsylvania at 1 site in United States.
Trial summary
We aim to test multiple interventions to improve sleep for Neurology inpatients, including 1) a sleep-friendly order set, and 2) a sleep menu. We will collect patient sleep data, including duration and quality, via actigraphy devices (FitBits). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep
- What is being tested?
- Sleep friendly order set and Patient sleep menu
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2023to 1 Jul 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- 24 hours after admission to the general neurology (ward) service at the Hospital of the University of Pennsylvania
- Patients who are determined by the primary team to be clinically stable enough to forego serial overnight vital signs monitoring and neuro checks.
- Clinical stability criteria:
- Symptomatic stability >24h after admission (no new or progressive neurologic symptoms for >24 hours)
- Vital signs stability on admission for > 24h while admitted
- Ability to verbally consent to study participation
Who cannot join
- Any medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
- Any additional clinical factors felt by the team to be incompatible with specific orders including requiring serial vital signs monitoring and neuro checks overnight
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
We aim to test multiple interventions to improve sleep for Neurology inpatients, including 1) a sleep-friendly order set, and 2) a sleep menu. We will collect patient sleep data, including duration and quality, via actigraphy devices (FitBits). We will also conduct qualitative patient surveys to understand the impact of these interventions.
- Conditions
- Sleep
- Being tested
- Sleep friendly order set, Patient sleep menu
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep friendly order setOther
Every evening, the following orders (which comprise the sleep-friendly order set) will be input into the EMR:
Hold vital signs and neurological checks overnight Retime applicable medications outside of the nighttime window of 10pm-6am Retime daily lab draws outside of the nighttime window of 10pm-6am Order melatonin if no clinical contraindications Discontinue finger stick glucose measurements for patients with a stable blood glucose values Change DVT prophylaxis to enoxaparin for all clinically eligible patients
Patient sleep menuOther
Patients will be given a menu of non-pharmacological options that support sleep by improving comfort and reducing anxiety.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | No intervention | Not described |
| Sleep intervention | Experimental | Not described Receives: Other: Sleep friendly order set; Other: Patient sleep menu |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fitbit Sleep Duration
Total hours of sleep
Measured: Duration of hospitalization from consent to discharge or day 10, whichever comes first
Secondary outcomes (3)
FitBit sleep score
The sleep score integrates subject sleep deprivation, sleep depth, and sleep restoration
Measured: Duration of hospitalization from consent to discharge or day 10, whichever comes first
Richard Campbell Sleep Questionnaire (RCSQ)
The Richards-Campbell Sleep Questionnaire (RCSQ) is a simple, validated survey instrument for measuring sleep quality in intensive care patients
Measured: Duration of hospitalization from consent to discharge or day 10, whichever comes first
Patient reported Sleep Duration and Quality
A brief survey collecting patient perceived duration and quality of sleep
Measured: Duration of hospitalization from consent to discharge or day 10, whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start30 Apr 2023
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Stein, University of Pennsylvania
- Investigators
- Laura Stein, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06094699
- Sponsor's protocol ID
- 850574
- Acronym
- I_SLEEP
- Status last verified
- Aug 2025
- First submitted
- 16 Oct 2023
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Sleep in the Neurology In-Patient Population
- ClinicalTrials.gov ID
- NCT06094699
- Acronym / sponsor ID
- I_SLEEP / 850574
- Conditions
- Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 30 Apr 2023 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 23 Oct 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.
We aim to test multiple interventions to improve sleep for Neurology inpatients, including 1) a sleep-friendly order set, and 2) a sleep menu. We will collect patient sleep data, including duration and quality, via actigraphy devices (FitBits). We will also conduct qualitative patient surveys to understand the impact of these interventions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | No intervention | – |
| Sleep intervention | Experimental | Other: Sleep friendly order set, Other: Patient sleep menu |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18
- 24 hours after admission to the general neurology (ward) service at the Hospital of the University of Pennsylvania
- Patients who are determined by the primary team to be clinically stable enough to forego serial overnight vital signs monitoring and neuro checks.
- Clinical stability criteria:
- Symptomatic stability >24h after admission (no new or progressive neurologic symptoms for >24 hours)
Key exclusion criteria (2 listed)
- Any medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
- Any additional clinical factors felt by the team to be incompatible with specific orders including requiring serial vital signs monitoring and neuro checks overnight
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 |
|---|---|---|
| Sleep friendly order setEvery evening, the following orders (which comprise the sleep-friendly order set) will be input into the EMR: Hold vital signs and neurological checks overnight Retime applicable medications outside of the nighttime window of 10pm-6am Retime daily lab draws outside of the nighttime window of 10pm-6am Order melatonin if no clinical contraindications Discontinue finger stick glucose measurements for patients with a stable blood glucose values Change DVT prophylaxis to enoxaparin for all clinically eligible patients | Other | Sleep intervention |
| Patient sleep menuPatients will be given a menu of non-pharmacological options that support sleep by improving comfort and reducing anxiety. | Other | Sleep intervention |
Primary outcome
Fitbit Sleep Duration
Time frame: Duration of hospitalization from consent to discharge or day 10, whichever comes first
Total hours of sleep
3 secondary outcomes
FitBit sleep score
Time frame: Duration of hospitalization from consent to discharge or day 10, whichever comes first
Richard Campbell Sleep Questionnaire (RCSQ)
Time frame: Duration of hospitalization from consent to discharge or day 10, whichever comes first
Patient reported Sleep Duration and Quality
Time frame: Duration of hospitalization from consent to discharge or day 10, whichever comes first
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 8 Aug 2025.
Related trials for Sleep
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
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.
Laura Stein principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep friendly order set and Patient sleep menu in people with Sleep, run by University of Pennsylvania 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 7 inclusion and 2 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 8 Aug 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?
Fitbit Sleep Duration (time frame: Duration of hospitalization from consent to discharge or day 10, whichever comes first). 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 8 Aug 2025.