Improving Sleep in the Neurology In-Patient Population

NCT ID: NCT06094699

Last Updated: 2025-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 145 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-30
• Study Completion Date: 2025-07-01

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.

Conditions

Sleep

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Sleep intervention

Group Type: EXPERIMENTAL

Sleep friendly order set

Intervention Type: 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

Intervention Type: OTHER

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

Interventions

Sleep friendly order set

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

Intervention Type: OTHER

Patient sleep menu

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Laura Stein

Principal Investgiator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laura Stein

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

850574

Identifier Type: -

Identifier Source: org_study_id