Sleep and circadian disruptors: Unhealthy noise and light levels for hospitalized pediatric patients.
Andrea L Fidler, Julie Waitt, Leslie E Lehmann...
https://pubmed.ncbi.nlm.nih.gov/37779507/Actively Recruiting
Led by Dana-Farber Cancer Institute · Updated on 2026-07-22
10
Participants Needed
2
Research Sites
8 weeks
Total Duration
This research focuses on pediatric patients aged 9 to 17 years who are undergoing stem cell transplant SCT and are at high risk for sleep disturbances during their extended hospital stays. Researchers aim to evaluate a program called DREAMS Developing Restful Environments and Management Strategies, designed to provide families with information and tools that may help support better sleep and circadian health during inpatient hospitalization. This single-arm pilot study is supported by the American Cancer Society and led by Dana-Farber Cancer Institute. The DREAMS program includes an introductory video about sleep experiences for SCT recipients, strategies to improve sleep, and a Sleep and Circadian Care Kit containing ear plugs, a white noise machine, an eye mask, a lightbox, and instructions. Participants and their families will also receive an Actigraph, Fitbit, and tablet to support the intervention. Study procedures involve a baseline survey, the standard stem cell infusion, an in-clinic visit to introduce the DREAMS program and kit, and a follow-up survey. Participants will be involved for about two weeks, during which surveys, sleep diaries, and patient-reported outcomes will be collected. Researchers will measure enrollment rate, acceptability of the intervention, usage of the care kit, and completion rates of assessments. Sleep disturbance questionnaires will be completed at baseline and follow-up. The study will help assess the feasibility and acceptability of delivering the DREAMS program to pediatric SCT patients and their families in a hospital setting.
CONDITIONS
Developing Restful Environments and Management Strategies for Pediatric Stem Cell Transplant Patients
L
Lucille Lokko, BA
E
Eric Zhou, PhD
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Dana-Farber Cancer Institute
Lead Sponsor
American Cancer Society, Inc.
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | DREAMS Program (interventional) | Usual Supportive Care (contextual) |
|---|---|---|
| What it is | A single‑arm pilot behavioral package including a video introduction plus a sleep‑support kit with ear plugs, white noise, eye mask, lightbox, actigraphy, Fitbit and tablet | Typical inpatient care without a dedicated structured program to support sleep and circadian rhythm |
| Role in study | Evaluated as the investigational intervention for feasibility and acceptability | Serves as implicit comparator representing usual care context |
| Purpose / primary use | To improve sleep and circadian support during inpatient pediatric stem cell transplant recovery | Provides general supportive care but without sleep‑focused environmental and behavioural tools |
| How it is given / performed | Families receive an introductory video and a care kit; monitoring tools (actigraph, Fitbit, tablet) are provided for home‑like circadian tracking | Care delivered through usual nursing and medical observation without standardized environmental tools or digital tracking |
| Evidence status | Feasibility and acceptability are being studied; effectiveness yet to be established | No guidelines or evidence support structured sleep/circadian interventions during pediatric SCT hospitalization |
| Important risks | Unknown; pilot design likely monitors for inconvenience or device misuse | Standard care risks include environmental sleep disruption effects |
| Important limitations | Single‑arm pilot without control group; small sample size (~10 participants); feasibility focus only | Based on typical practice, not systematically studied or standardized across settings |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - About 2 weeks
Participants receive the DREAMS program introduction, Sleep and Circadian Care Kit, Actigraph, and Fitbit. They complete baseline and follow-up surveys and wear devices to monitor sleep during their hospital stay.
Baseline visit, in-clinic intervention visit, and follow-up assessment visit
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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Andrea L Fidler, Julie Waitt, Leslie E Lehmann...
https://pubmed.ncbi.nlm.nih.gov/37779507/Dana-Farber Cancer Institute
Lead Sponsor
American Cancer Society, Inc.
Collaborating Sponsor