NCT06094699

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 30, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

August 8, 2025

Status Verified

August 1, 2025

Enrollment Period

2.2 years

First QC Date

October 16, 2023

Last Update Submit

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 INTERVENTION

Sleep intervention

EXPERIMENTAL
Other: Sleep friendly order setOther: Patient sleep menu

Interventions

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

Sleep intervention

Patients will be given a menu of non-pharmacological options that support sleep by improving comfort and reducing anxiety.

Sleep intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

Study Officials

  • Laura Stein

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

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

Locations