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OpenTrials
Completed

NCT Number: NCT06094699

Improving Sleep in the Neurology In-Patient Population

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Sleep friendly order set

Other

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 menu

Other

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

Primary outcomes

  1. Fitbit Sleep Duration

    Time frame: Duration of hospitalization from consent to discharge or day 10, whichever comes first

    Total hours of sleep

Secondary outcomes

  1. FitBit sleep score

    Time frame: Duration of hospitalization from consent to discharge or day 10, whichever comes first

    The sleep score integrates subject sleep deprivation, sleep depth, and sleep restoration

  2. Richard Campbell Sleep Questionnaire (RCSQ)

    Time frame: Duration of hospitalization from consent to discharge or day 10, whichever comes first

    The Richards-Campbell Sleep Questionnaire (RCSQ) is a simple, validated survey instrument for measuring sleep quality in intensive care patients

  3. Patient reported Sleep Duration and Quality

    Time frame: Duration of hospitalization from consent to discharge or day 10, whichever comes first

    A brief survey collecting patient perceived duration and quality of sleep

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Acronym: I_SLEEP

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 23, 2023
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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