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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hematological Malignancies
• Intervention / Treatment: Other: Weighted Blanket

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Platelet count of 25 or below
2. History of seizures/intracranial metastasis/ sleep apnea/restless leg syndrome/paralysis
3. Weight less than 150 lbs.
4. Attending physician assessment of prognosis with expected life expectancy of <1 month
5. 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.
6. Patients with difficulty breathing, disorders of poor circulation, fragile skin, rash, or open wounds, or by those who are claustrophobic or cleithrophobic.
7. Prior use of weighted blankets within the past 1-year

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients more than 200 pounds	Other: Weighted Blanket; Participants will be given a weighted blanket
Experimental: Patients between 150-200 pounds	Other: Weighted Blanket; Participants will be given a weighted blanket

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Adverse Events (AEs)	Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0	Through study completion; an average of 1 year

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: Gabrielles Angel FDN for Cancer Research
• Investigators: Principal Investigator: Santhosshi Narayanan, MBBS, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: September 3, 2024
• First Submitted That Met QC Criteria: September 3, 2024
• First Posted (Actual): September 5, 2024

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Hematologic Neoplasms
• Other Study ID Numbers: 2024-0464; NCI-2024-07498 (Other Identifier: NCI-CTRP Clinical Trials Registry)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No