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New treatment option for Chronic Pain
Official title Weighted Blanket Use for Adults With Chronic Pain
ClinicalTrials.gov ID: NCT07498491
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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).
You likely can't join if
- 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)...
- Cancer: Lung cancer
See the full eligibility 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.
- 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'...
The study team makes the final eligibility decision.
Where it's taking place
- Portland, Oregon, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Portland, Oregon, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.