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OpenTrials
Active, Not Recruiting

NCT Number: NCT06584955

Feasibility of the Use of Weighted Blankets to Improve Sleep Among Patients With Hematological Malignancies

The goal of this clinical research study is to learn about the effects of weighted blankets on sleep quality in patients with blood cancers. Weighted blankets are heavier blankets that contain inner weight beads. The deep pressure stimulation induced by these blankets can have a calming effect.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

Primary Objective:

To determine the feasibility of using weighted blankets to improve Sleep Disturbances (SD) for patients with hematological malignancies in an outpatient setting.

Secondary Objectives:

To explore if weighted blanket use improves sleep as assessed by the ESAS sleep question. A positive response is defined by at least a one-point reduction in ESAS sleep between baseline and day 7 +/-2 days.

To explore if weighted blanket use during a 14-day period improves Insomnia Severity Index (ISI) score.

To explore the response rate in anxiety, where response is defined as a minimum of one-point change in the ESAS anxiety score, between baseline and day 7 +/-2 days after the use of weighted blankets.

To explore if patients are satisfied with the use of weighted blankets as determined by a positive response to at least 2 of the 5 patient satisfaction questions.

To assess safety using NCI CTCAE v5

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Outpatient at MD Anderson Cancer Center
  • Adult patients ≥ 18 years
  • Diagnosis of hematological malignancy
  • ESAS Sleep>/=4
  • Performance status as measured by Eastern Cooperative Oncology Practice group (ECOG) score of 2 or below

Exclusion criteria

  • Platelet count of 25 or below
  • History of seizures/intracranial metastasis/ sleep apnea/restless leg syndrome/paralysis
  • Weight less than 150 lbs.
  • Attending physician assessment of prognosis with expected life expectancy of <1 month
  • Patients who are unable to tolerate their blankets/sheets in the night due to medical conditions such as pain, peripheral neuropathy, night sweats, hot flashes etc.
  • Patients with difficulty breathing, disorders of poor circulation, fragile skin, rash, or open wounds, or by those who are claustrophobic or cleithrophobic.
  • Prior use of weighted blankets within the past 1-year

Treatment and study plan

Weighted Blanket

Other

Participants will be given a weighted blanket

Primary outcomes

  1. Safety and Adverse Events (AEs)

    Time frame: Through study completion; an average of 1 year

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • Gabrielles Angel FDN for Cancer Research

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 5, 2024
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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