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Sleep After Pediatric Critical Illness

Primary Purpose

Pediatric, Critical Illness, Sleep Disturbance

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sleep education
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pediatric

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 6 years to 18 years inclusive Inpatient consult to Pediatric Critical Care and Neurotrauma Recovery Program Exclusion Criteria: Abusive trauma Child protective services custody Prisoners Pregnancy Non-English speaking caregivers

Sites / Locations

  • Oregon Health & Science UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Other

Arm Label

Before- standard care

After- intervention

Arm Description

Patients studied in this arm receive the new educational intervention delivered in conjunction with standard care

Outcomes

Primary Outcome Measures

Sleep Disturbances Scale for Children
26-item parent report sleep measure

Secondary Outcome Measures

Pediatric Quality of Life Inventory Scale (PedsQL)
Parent rated quality of life measure, age based

Full Information

First Posted
May 18, 2023
Last Updated
May 18, 2023
Sponsor
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT05879640
Brief Title
Sleep After Pediatric Critical Illness
Official Title
Sleep Disturbances for Children After Critical Care: Pilot Sleep Education Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 18, 2022 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study tests a pilot educational sleep intervention for children after critical care hospitalization.
Detailed Description
We are conducting a before-after study evaluating an educational intervention delivered during hospitalization on sleep outcomes 1month after critical care hospitalization for children aged 6 to 18 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric, Critical Illness, Sleep Disturbance

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Before-after
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Before- standard care
Arm Type
No Intervention
Arm Title
After- intervention
Arm Type
Other
Arm Description
Patients studied in this arm receive the new educational intervention delivered in conjunction with standard care
Intervention Type
Behavioral
Intervention Name(s)
Sleep education
Intervention Description
Participants receive a handout about age appropriate sleep goals and tips for improving sleep. The handout also contains links to educational videos about sleep hygiene and the importance of sleep to healing after illness. The handout is reviewed with a clinician at bedside prior to hospital discharge.
Primary Outcome Measure Information:
Title
Sleep Disturbances Scale for Children
Description
26-item parent report sleep measure
Time Frame
1-month
Secondary Outcome Measure Information:
Title
Pediatric Quality of Life Inventory Scale (PedsQL)
Description
Parent rated quality of life measure, age based
Time Frame
1-month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 6 years to 18 years inclusive Inpatient consult to Pediatric Critical Care and Neurotrauma Recovery Program Exclusion Criteria: Abusive trauma Child protective services custody Prisoners Pregnancy Non-English speaking caregivers
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cydni Williams, MD, MCR
Phone
5034945522
Email
willicyd@ohsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cydni Williams, MD, MCR
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cydni Williams, MD
Phone
503-494-5522
Email
willicyd@ohsu.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Sleep After Pediatric Critical Illness

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