Improving Sleep in the Neurology In-Patient Population
I_SLEEP
1 other identifier
interventional
145
1 country
1
Brief 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). We will also conduct qualitative patient surveys to understand the impact of these interventions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 30, 2023
CompletedFirst Submitted
Initial submission to the registry
October 16, 2023
CompletedFirst Posted
Study publicly available on registry
October 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2025
CompletedAugust 8, 2025
August 1, 2025
2.2 years
October 16, 2023
August 7, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Fitbit Sleep Duration
Total hours of sleep
Duration of hospitalization from consent to discharge or day 10, whichever comes first
Secondary Outcomes (3)
FitBit sleep score
Duration of hospitalization from consent to discharge or day 10, whichever comes first
Richard Campbell Sleep Questionnaire (RCSQ)
Duration of hospitalization from consent to discharge or day 10, whichever comes first
Patient reported Sleep Duration and Quality
Duration of hospitalization from consent to discharge or day 10, whichever comes first
Study Arms (2)
Standard of care
NO INTERVENTIONSleep intervention
EXPERIMENTALInterventions
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
Patients will be given a menu of non-pharmacological options that support sleep by improving comfort and reducing anxiety.
Eligibility Criteria
You may qualify if:
- Age ≥ 18
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Laura Stein
University of Pennsylvania
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investgiator
Study Record Dates
First Submitted
October 16, 2023
First Posted
October 23, 2023
Study Start
April 30, 2023
Primary Completion
July 1, 2025
Study Completion
July 1, 2025
Last Updated
August 8, 2025
Record last verified: 2025-08