NCT07498491 Weighted Blanket Use for Adults With Chronic Pain
| NCT ID | NCT07498491 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National University of Natural Medicine |
| Condition | Chronic Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 44 participants |
| Start Date | 2026-05-27 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 44 participants in total. It began in 2026-05-27 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Chronic pain is a common condition that can affect sleep, daily functioning, and overall quality of life. Many individuals living with chronic pain seek non-medication approaches to help manage their symptoms. Weighted blankets are commonly used to promote relaxation and comfort during sleep, but there is limited research examining their potential role in supporting people with chronic pain. This pilot study will explore the experiences of adults with chronic pain who use a weighted blanket during sleep. The study aims to better understand whether nightly use of a weighted blanket may be associated with changes in pain, sleep, and daily functioning. Findings from this study will help inform future research on non-medication approaches to managing chronic pain. Approximately 44 adults with chronic pain will participate in the study. Participation will last about five weeks. After completing a virtual enrollment visit and baseline questionnaires, participants will receive a weighted blanket sized to approximately 10 percent of their body weight. Participants will first complete a 7-day adjustment period using the blanket while sleeping. If they tolerate the blanket and use it nightly during this period, they will continue into a 4-week study phase in which they will use the weighted blanket each night. During the study, participants will complete brief online surveys about their experiences and adherence to using the blanket. Pain and quality-of-life questionnaires will be completed at multiple time points, including at the start and end of the study. Participants will also provide feedback about their experience using the weighted blanket. Results from this pilot study will help researchers better understand how weighted blankets may be used by adults with chronic pain and may help guide the design of future studies evaluating non-pharmacologic approaches to pain management.
Eligibility Criteria
Inclusion Criteria: * Age: Male and non-pregnant female adult participants must 18 years of age or older * Duration of pain: at least 3 months * Average Pain Intensity over the past week: ≥3/10 NRS * Safely able to lift a weighted blanket that is 10% of the participant's self-reported body weight (10-25 lbs.) without assistance. * Willing to sleep with a weighted blanket (10-25 lbs.) for a total of 35 (7 days for Run-In/Adjustment + 28 days of trial). * Willing to maintain current dietary patterns, activity level, and stable body weight for the duration of the study. * Willing to undergo study procedures, including completion of online questionnaires and surveys, and attend virtual study visits. * Informed Consent: Participants must be able to provide informed consent and comply with the study procedure. * Able to speak, read, and understand English. * Able to access WIFI to attend virtual visits and complete study surveys. Exclusion Criteria: * Age: Participants younger than 18 years old. * Currently using a weighted blanket (will have opportunity for washout period) * Inability to lift a 10-25 lbs. (10% of body weight) weighted blanket without assistance. * Inability or unwillingness to sleep with the weighted blanket nightly * Breathing/Respiratory Issue: Obstructive sleep apnea (OSA), Chronic obstructive Pulmonary Disease (COPD- includes emphysema and chronic bronchitis), Tuberculosis (TB), severe asthma * Cancer: Lung cancer * Cardiovascular Disease: Congestive heart failure (CHF), severe cardiomyopathy * Circulatory Issues: Severe peripheral artery disease (PAD), severe or uncontrolled Type 2 Diabetes * Recent surgery: Participants who recently had surgery and/or have an open wound. * Pregnancy or Lactation: Individuals who are pregnant, lactating, or planning a pregnancy within the next 35 days. * Co-sleeping: Individuals who co-sleep with their infant or young child. * Allergies: Known allergy or hypersensitivity to any component of the study products (including cotton material, natural and plant-based dyes). * Claustrophobia * Participation in Other Pain Trials: Currently participating in another pain research study. * Any condition that, in the opinion of the Investigator, does not justify the individuals' participation in the study that may impact their safety or confound trial results. This includes an increase in the participants' pain intensity during the baseline week or the active part of the trial.
Contact & Investigator
Carina Staab, DC, MEd
PRINCIPAL INVESTIGATOR
National University of Natural Medicine
Frequently Asked Questions
Who can join the NCT07498491 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07498491 currently recruiting?
Yes, NCT07498491 is actively recruiting participants. Contact the research team at cstaab@nunm.edu for enrollment information.
Where is the NCT07498491 trial being conducted?
This trial is being conducted at Portland, United States.
Who is sponsoring the NCT07498491 clinical trial?
NCT07498491 is sponsored by National University of Natural Medicine. The principal investigator is Carina Staab, DC, MEd at National University of Natural Medicine. The trial plans to enroll 44 participants.
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