PediatricNCT05879640
Sleep After Pediatric Critical Illness
A study testing Sleep education in people with Pediatric and Critical Illness, run by Oregon Health and Science University at 1 site in United States.
Trial summary
This study tests a pilot educational sleep intervention for children after critical care hospitalization. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Pediatric, Critical Illness, Sleep Disturbance
- What is being tested?
- Sleep education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 6 years to 18 years inclusive
- Inpatient consult to Pediatric Critical Care and Neurotrauma Recovery Program
Who cannot join
- Abusive trauma
- Child protective services custody
- Prisoners
- Pregnancy
- Non-English speaking caregivers
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Sleep Disturbances for Children After Critical Care: Pilot Sleep Education Intervention
This study tests a pilot educational sleep intervention for children after critical care hospitalization.
Read the detailed description
The investigators 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.
- Conditions
- Pediatric, Critical Illness, Sleep Disturbance
- Being tested
- Sleep education
- Medical subject headings
- Critical Illness, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep educationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Before- standard care | No intervention | Not described |
| After- intervention | Other | Patients studied in this arm receive the new educational intervention delivered in conjunction with standard care Receives: Behavioral: Sleep education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Disturbances Scale for Children
26-item parent report sleep measure; generates total T-score and 6 subscale T-scores (range 0-100, M 50, SD 10)
Measured: 1-month
Secondary outcomes (1)
Pediatric Quality of Life Inventory Scale (PedsQL)
Parent rated quality of life measure, age based; Generates total score 0-100
Measured: 1-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start18 Apr 2022
- Primary completion30 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PediatricStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Before-after
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cydni Williams, Oregon Health and Science University
- Investigators
- Cydni Williams, MD, MCR, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05879640
- Sponsor's protocol ID
- 23234
- Status last verified
- Apr 2024
- First submitted
- 18 May 2023
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Disturbances for Children After Critical Care: Pilot Sleep Education Intervention
- ClinicalTrials.gov ID
- NCT05879640
- Acronym / sponsor ID
- 23234
- Conditions
- Pediatric, Critical Illness, Sleep Disturbance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 18 Apr 2022 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 30 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study tests a pilot educational sleep intervention for children after critical care hospitalization.
Detailed description
The investigators 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Before-after
| Arm | Type | Receives |
|---|---|---|
| Before- standard care | No intervention | – |
| After- intervention | Other | Behavioral: Sleep educationPatients studied in this arm receive the new educational intervention delivered in conjunction with standard care |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Age 6 years to 18 years inclusive
- Inpatient consult to Pediatric Critical Care and Neurotrauma Recovery Program
Key exclusion criteria (5 listed)
- Abusive trauma
- Child protective services custody
- Prisoners
- Pregnancy
- Non-English speaking caregivers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep educationParticipants 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. | Behavioural | After- intervention |
Primary outcome
Sleep Disturbances Scale for Children
Time frame: 1-month
26-item parent report sleep measure; generates total T-score and 6 subscale T-scores (range 0-100, M 50, SD 10)
1 secondary outcome
Pediatric Quality of Life Inventory Scale (PedsQL)
Time frame: 1-month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cydni Williams, MD, MCR principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep education in people with Pediatric and Critical Illness, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Disturbances Scale for Children (time frame: 1-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.