Other Clinical Trial - Sleep in Pediatric HSCT

Status Completed

Clinical 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 nighttime sleep (intervention) relative to regular vitals checks (observation only periods) during Hematopoietic Stem Cell Transplant (HSCT) recovery.

Clinical Trial 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

Related Conditions & MeSH terms

Sleep
Stem Cell Transplant Complications

Clinical Trial Details

NCT number	NCT04106089
Study type	Interventional
Source	Children's Hospital of Philadelphia
Contact
Status	Completed
Phase	N/A
Start date	November 18, 2019
Completion date	December 1, 2022

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04044495` - Sleep, Rhythms and Risk of Alzheimer's Disease	N/A
Recruiting	`NCT06079853` - Nurse Suicide: Physiologic Sleep Health Promotion Trial	N/A
Completed	`NCT05017974` - Research on Improving Sleep During Pregnancy	N/A
Recruiting	`NCT05206747` - Ottawa Sunglasses at Night for Mania Study	N/A
Enrolling by invitation	`NCT04253054` - Chinese Multi-provincial Cohort Study-Beijing Project
Completed	`NCT04513743` - Ultra Long-Term Sleep Monitoring Using UNEEG™ Medical 24/7 EEG™ SubQ	N/A
Completed	`NCT03251274` - Bath Machine on Sleep Quality in Nursing Home	N/A
Completed	`NCT04102345` - Lavender vs Zolpidem Sleep Quality During Diagnostic PSG	Early Phase 1
Completed	`NCT03725943` - Comparison of Dreem to Clinical PSG for Sleep Monitoring in Healthy Adults	N/A
Active, not recruiting	`NCT05062161` - Sleep Duration and Blood Pressure During Sleep	N/A
Completed	`NCT04562181` - Consistency Evaluation of the qCON, qNOX Indices and Bispectral Index	N/A
Completed	`NCT05576844` - Ai Youmian (Love Better Sleep) for People Living With HIV	N/A
Completed	`NCT05102565` - A Dyadic Telehealth Program for Alzheimer's Patients/Caregivers	N/A
Enrolling by invitation	`NCT04688099` - Synovial Fluid Sleep Study
Recruiting	`NCT04171245` - Prescribing Laughter for Sleep and Wellbeing in UAE University Students	N/A
Completed	`NCT03758768` - The Effects of a Blue Monochromatic Light Intervention on Evening-type Individuals' Sleep and Circadian Rhythms	N/A
Completed	`NCT03163498` - Evaluation of Sleep Pattern and Mood Profile in Hypertensive Patients
Completed	`NCT04093271` - Investigating the Efficacy of Rest-ZZZ Formula in Healthy Participants With Difficulty Falling Asleep or Staying a Sleep	Phase 1
Completed	`NCT03673397` - The Acute Effect of Aerobic Exercise on Sleep in Patients With Depression	N/A
Completed	`NCT04120363` - Trial of Testosterone Undecanoate for Optimizing Performance During Military Operations	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.