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Sleep Improvement Interventions for Inpatients with Neurological Conditions (I_SLEEP Trial)

N/A

Recruiting

Led By Laura Stein

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ability to verbally consent to study participation

Age ≥ 18

Timeline

Screening 3 weeks

Treatment Varies

Follow Up duration of hospitalization from consent to discharge or day 10, whichever comes first

Awards & highlights

I_SLEEP Trial Summary

This trial tests interventions to improve sleep for inpatients with neurological conditions, like FitBits to measure duration & quality, plus surveys to understand impact.

Who is the study for?

This trial is for adults over 18 who have been admitted to the general neurology ward at the Hospital of the University of Pennsylvania and are stable enough not to need overnight vital signs or neurological checks. They must be symptomatically stable for more than 24 hours and able to give verbal consent.Check my eligibility

What is being tested?

The study tests two interventions aimed at improving sleep quality in neurology inpatients: a set of orders designed with sleep in mind, and a menu tailored to promote better sleep. Sleep data will be tracked using FitBits, and patient surveys will assess these interventions' effectiveness.See study design

What are the potential side effects?

There may not be direct side effects from participating as this trial involves non-pharmaceutical measures like order sets and menus. However, participants might experience discomfort wearing actigraphy devices during sleep or potential privacy concerns with data collection.

I_SLEEP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can verbally agree to join the study.

Select...

I am 18 years old or older.

I_SLEEP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ duration of hospitalization from consent to discharge or day 10, whichever comes first

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~duration of hospitalization from consent to discharge or day 10, whichever comes first

This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of hospitalization from consent to discharge or day 10, whichever comes first for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Fitbit Sleep Duration

Secondary outcome measures

FitBit sleep score

Patient reported Sleep Duration and Quality

Richard Campbell Sleep Questionnaire (RCSQ)

I_SLEEP Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Sleep interventionExperimental Treatment2 Interventions

Group II: Standard of careActive Control1 Intervention

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,005 Previous Clinical Trials

42,882,157 Total Patients Enrolled

6 Trials studying Sleep

3,660 Patients Enrolled for Sleep

Laura SteinPrincipal InvestigatorUniversity of Pennsylvania

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants able to join this research experiment at the present?

"The research team has posted the clinical trial on 4/30/2023, as stated in clinicaltrials.gov, and is currently recruiting participants with the last update made on 10/16/2023."

Answered by AI

What is the cap on patient involvement in this research?

"Correct. Data hosted on clinicaltrials.gov confirms that this medical study, which was initially posted on April 30th 2023, is actively recruiting. 130 patients need to be enrolled from one centre of care."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Improving Sleep in the Neurology In-Patient Population

Laura Stein 2023. "Improving Sleep in the Neurology In-Patient Population". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06094699.