SleepNCT04106089
Sleep in Pediatric HSCT
A study testing Extended time between vitals check in people with Sleep and Stem Cell Transplant Complications, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
Through an aggregated N=1 randomized controlled design (each patient will serve as their own control, with the 5-day intervention period determined by randomization), the current study will test the acceptability, feasibility, and impact on sleep and supportive care engagement of protecting one 6-hour window for… Read more about this study
- Who is it for?
- Ages 8 to 21 years
- Conditions the study is for
- Sleep, Stem Cell Transplant Complications
- What is being tested?
- Extended time between vitals check
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2019to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 8 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Males or females age 8 to 21 years.
- Undergoing HSCT at The Children's Hospital of Philadelphia
- Parent/guardian permission (informed consent) and if appropriate, child assent.
Who cannot join
- History of developmental delays given the relationship to sleep/wake patterns
- Sleep disorder diagnosis as documented in the medical record
- Cognitive delays that impact the ability to complete study measures
- Not proficient in English
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Sleep in Pediatric Hematopoietic Stem Cell Transplant Patients
Through an aggregated N=1 randomized controlled design (each patient will serve as their own control, with the 5-day intervention period determined by randomization), the current study will test the acceptability, feasibility, and impact on sleep and supportive care engagement of protecting one 6-hour window for nighttime sleep (intervention) relative to regular vitals checks (observation only periods) during Hematopoietic Stem Cell Transplant (HSCT) recovery.
Read the detailed description
Context: Patients undergoing treatment for cancer face disease, treatment, and environmental obstacles to sufficient, sound sleep. Hospitalizations can further worsen sleep quality and quantity due to overnight vitals checks, medication administration, blood draws, and environmental noise and light. For patients undergoing hematopoietic stem cell transplant (HSCT), the risk for poor sleep is especially high due to protracted hospitalization, frequent vitals checks resulting in multiple night awakenings, and high symptom burden peaking approximately 10 days post-transplant.
Objectives:
Primary: Test the acceptability and feasibility of protecting one 6-hour window for nighttime sleep (intervention) relative to regular vitals checks (observation only periods) during HSCT recovery.
Secondary: Assess the effect of one 6-hour window for nighttime sleep on subject sleep and engagement in supportive care on the oncology unit.
Study Design:
Aggregated N=1 randomized controlled design. All participants will undergo a 5 day observation and then be randomized to receive the 5 day intervention (extended vitals checks) during either nights of days +5-+9 or days +10-+14.
Setting/Participants:
Inpatients on the HSCT Unit at the Children's Hospital of Philadelphia (CHOP)
Study Interventions and Measures:
Intervention-increasing time between vitals checks from every 4 hours to one 6-hour period at night.
Subjects will wear an actigraph for the duration of the study, complete a daily sleep diary, and complete self- and parent-proxy psychosocial measures (symptom burden, health related quality of life, sleep) and acceptability. Medical record review will also be conducted to assess vitals check frequency.
- Conditions
- Sleep, Stem Cell Transplant Complications
- Being tested
- Extended time between vitals check
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended time between vitals checkBehavioural
Participants will have 6 hours protected sleep time (vitals checks moved from every 4 to every 6 hours)
| Study group | Role | What they receive |
|---|---|---|
| Observation-Intervention-Observation | Experimental | 5 days of observation, 5 days of extended vitals check, 5 days returning to regular vitals checks Receives: Behavioral: Extended time between vitals check |
| Observation-Observation-Intervention | Experimental | 5 days of observation, 5 more days of observation, 5 days of extended vitals check Receives: Behavioral: Extended time between vitals check |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Acceptability Questionnaire
Brief questionnaire created for this study evaluating the patient's acceptability of adjusting vitals checks. Participants reported agreement with each statement on a 5-point likert scale from not at all (1) to extremely (5). Higher values indicate greater agreement.
Measured: 15 days after transplant
Parent Acceptability Questionnaire
Brief questionnaire created for this study evaluating the patient's acceptability of adjusting vitals checks. Participants reported agreement with each statement on a 5-point likert scale from not at all (1) to extremely (5). Higher values indicate greater agreement.
Measured: 15 days after transplant
Nurse Acceptability Questionnaire
Brief questionnaire created for this study evaluating the nurse's acceptability of adjusting vitals checks. Nurses reported agreement with each statement on a 5-point likert scale from not at all (1) to extremely (5). Higher values indicate greater agreement.
Measured: 15 days after transplant
Health-related Quality of Life (HRQL)
Using the Pediatric Quality of Life Inventory - Stem Cell Transplant (SCT) module. Scale values range from 0 to 100, with higher scores indicating better functioning.
Measured: 15 days after transplant
Secondary outcomes (3)
Actigraphy Sleep Efficiency
Sleep efficiency is the percentage of time spent asleep, while in bed. It is calculated by dividing the time spent asleep, by the total amount of time in bed.
Measured: Day of the transplant through 15 days after the transplant
Actigraphy Total Sleep Time
This will measure the total amount of time the subject sleeps each day in minutes.
Measured: Day of the transplant through 15 days after the transplant
Actigraphy Awakenings-minutes Per Day
This measure the number of minutes per day the subject awakens from rest during nighttime sleep per day.
Measured: Day of the transplant through 15 days after the transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start18 Nov 2019
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Crossover
- Model description
- Aggregated N of 1 design (ABA or AAB)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Rutgers University, NJ Dept of Health Commission on Cancer Research
- Responsible party
- Sponsor
- Investigators
- Lamia Barakat, PhD, Principal investigator, CHOP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04106089
- Sponsor's protocol ID
- 18-015878
- Other IDs
- DCHS20PPR006
- Status last verified
- Oct 2024
- First submitted
- 25 Sep 2019
- Last updated
- 18 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Daniel LC, Venella KL, Woodard K, Poliakova P, Gross JY, Bercovitz IN, Moore D, Barakat LP, Freedman JL. Can extending time between vital sign checks improve sleep in hematopoietic stem cell transplant patients? Testing feasibility, acceptability, and preliminary efficacy. Pediatr Blood Cancer. 2024 Apr;71(4):e30832. doi: 10.1002/pbc.30832. Epub 2024 Jan 10.
PubMed 38197636
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep in Pediatric Hematopoietic Stem Cell Transplant Patients
- ClinicalTrials.gov ID
- NCT04106089
- Acronym / sponsor ID
- 18-015878
- Conditions
- Sleep, Stem Cell Transplant Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Rutgers University, NJ Dept of Health Commission on Cancer Research
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 26 Sep 2019 (actual)
- Results
- Posted 18 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Through an aggregated N=1 randomized controlled design (each patient will serve as their own control, with the 5-day intervention period determined by randomization), the current study will test the acceptability, feasibility, and impact on sleep and supportive care engagement of protecting one 6-hour window for nighttime sleep (intervention) relative to regular vitals checks (observation only periods) during Hematopoietic Stem Cell Transplant (HSCT) recovery.
Detailed description
Context: Patients undergoing treatment for cancer face disease, treatment, and environmental obstacles to sufficient, sound sleep. Hospitalizations can further worsen sleep quality and quantity due to overnight vitals checks, medication administration, blood draws, and environmental noise and light. For patients undergoing hematopoietic stem cell transplant (HSCT), the risk for poor sleep is especially high due to protracted hospitalization, frequent vitals checks resulting in multiple night awakenings, and high symptom burden peaking approximately 10 days post-transplant.
Objectives:
Primary: Test the acceptability and feasibility of protecting one 6-hour window for nighttime sleep (intervention) relative to regular vitals checks (observation only periods) during HSCT recovery.
Secondary: Assess the effect of one 6-hour window for nighttime sleep on subject sleep and engagement in supportive care on the oncology unit.
Study Design:
Aggregated N=1 randomized controlled design. All participants will undergo a 5 day observation and then be randomized to receive the 5 day intervention (extended vitals checks) during either nights of days +5-+9 or days +10-+14.
Setting/Participants:
Inpatients on the HSCT Unit at the Children's Hospital of Philadelphia (CHOP)
Study Interventions and Measures:
Intervention-increasing time between vitals checks from every 4 hours to one 6-hour period at night.
Subjects will wear an actigraph for the duration of the study, complete a daily sleep diary, and complete self- and parent-proxy psychosocial measures (symptom burden, health related quality of life, sleep) and acceptability. Medical record review will also be conducted to assess vitals check frequency.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Aggregated N of 1 design (ABA or AAB)
| Arm | Type | Receives |
|---|---|---|
| Observation-Intervention-Observation | Experimental | Behavioral: Extended time between vitals check5 days of observation, 5 days of extended vitals check, 5 days returning to regular vitals checks |
| Observation-Observation-Intervention | Experimental | Behavioral: Extended time between vitals check5 days of observation, 5 more days of observation, 5 days of extended vitals check |
Who may qualify
- Ages
- 8 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Males or females age 8 to 21 years.
- Undergoing HSCT at The Children's Hospital of Philadelphia
- Parent/guardian permission (informed consent) and if appropriate, child assent.
Key exclusion criteria (4 listed)
- History of developmental delays given the relationship to sleep/wake patterns
- Sleep disorder diagnosis as documented in the medical record
- Cognitive delays that impact the ability to complete study measures
- Not proficient in English
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 |
|---|---|---|
| Extended time between vitals checkParticipants will have 6 hours protected sleep time (vitals checks moved from every 4 to every 6 hours) | Behavioural | Observation-Intervention-Observation, Observation-Observation-Intervention |
Primary outcome
Patient Acceptability Questionnaire
Time frame: 15 days after transplant
Brief questionnaire created for this study evaluating the patient's acceptability of adjusting vitals checks. Participants reported agreement with each statement on a 5-point likert scale from not at all (1) to extremely (5). Higher values indicate greater agreement.
Parent Acceptability Questionnaire
Time frame: 15 days after transplant
Brief questionnaire created for this study evaluating the patient's acceptability of adjusting vitals checks. Participants reported agreement with each statement on a 5-point likert scale from not at all (1) to extremely (5). Higher values indicate greater agreement.
Nurse Acceptability Questionnaire
Time frame: 15 days after transplant
Brief questionnaire created for this study evaluating the nurse's acceptability of adjusting vitals checks. Nurses reported agreement with each statement on a 5-point likert scale from not at all (1) to extremely (5). Higher values indicate greater agreement.
Health-related Quality of Life (HRQL)
Time frame: 15 days after transplant
Using the Pediatric Quality of Life Inventory - Stem Cell Transplant (SCT) module. Scale values range from 0 to 100, with higher scores indicating better functioning.
3 secondary outcomes
Actigraphy Sleep Efficiency
Time frame: Day of the transplant through 15 days after the transplant
Actigraphy Total Sleep Time
Time frame: Day of the transplant through 15 days after the transplant
Actigraphy Awakenings-minutes Per Day
Time frame: Day of the transplant through 15 days after the transplant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 38197636Daniel LC, Venella KL, Woodard K, Poliakova P, Gross JY, Bercovitz IN, Moore D, Barakat LP, Freedman JL. Can extending time between vital sign checks improve sleep in hematopoietic stem cell transplant patients? Testing feasibility, acceptability, and preliminary efficacy. Pediatr Blood Cancer. 2024 Apr;71(4):e30832. doi: 10.1002/pbc.30832. Epub 2024 Jan 10.
- 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.
Lamia Barakat, PhD principal investigator
CHOP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extended time between vitals check in people with Sleep and Stem Cell Transplant Complications, run by Children's Hospital of Philadelphia 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 3 inclusion and 4 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 18 Oct 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?
Yes. Results are posted in the registry (first posted 18 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Patient Acceptability Questionnaire (time frame: 15 days after transplant). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04106089, which also lists 1 linked publication.
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 18 Oct 2024.