Improving Sleep in the Neurology In-Patient Population

Sleep Clinical Trial

— I_SLEEP  

Official title:

Improving Sleep in the Neurology In-Patient Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06094699
• Other study ID #: 850574
• Status: Recruiting
• Phase: N/A
• Start date: April 30, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: October 2023
• Source: University of Pennsylvania
• Contact: Laura Stein, MD
• Phone: 215-662-6214
• Email: laura.stein[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). We will also conduct qualitative patient surveys to understand the impact of these interventions.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sleep

Intervention

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

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fitbit Sleep Duration	Total hours of sleep	Duration of hospitalization from consent to discharge or day 10, whichever comes first
Secondary	FitBit sleep score	The sleep score integrates subject sleep deprivation, sleep depth, and sleep restoration	Duration of hospitalization from consent to discharge or day 10, whichever comes first
Secondary	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	Duration of hospitalization from consent to discharge or day 10, whichever comes first
Secondary	Patient reported Sleep Duration and Quality	A brief survey collecting patient perceived duration and quality of sleep	Duration of hospitalization from consent to discharge or day 10, whichever comes first