Effect of Semiconductor Embedded Wearable Sleeve on Treatment of Primary Dysmenorrhea Symptoms

NCT07176780 | Not Yet Recruiting

• 1 other identifier: 2264207
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is looking to test a non-compressive semiconductor embedded body sleeve for treatment of primary dysmenorrhea symptoms. Dysmenorrhea is the lower abdominal pain (sometimes referred to as "cramping") experienced during menstruation (monthly "period"), affecting up to 94% of people aged from 10-20 years old. The semiconductor embedded fabric increases blood circulation through activation of the embedded elements with body heat while worn and releases energy waves as well as negative ions. This energy has an effect inside the body that increases oxygen and nutrient flow to tissues, and can help to decrease pain and inflammation. This study is testing this technology to see if it can be used as a non-pharmacological treatment for menstrual cramping.

Conditions

Primary Dysmenorrhea; Primary Dysmenorrhea (PD); Menstrual Cramps; Women's Health

Keywords

Menstrual Cramps; Dysmenorrhea; Primary Dysmenorrhea; Women's Health

Outcome Measures

Primary Outcomes (1)

• Participant-Reported Changes in Pain

  Reduction in menstrual symptom severity as determined by the Visual Analog Scale (VAS) compared to placebo group: Visual Analog Scale for Pain (VAS) Minimum value: 0 (no pain) Maximum value: 10 (worst possible pain)

  6 months

Secondary Outcomes (5)

• Participant-Reported Changes in Quality of Life

  6 months

• Changes in oral medication intake compared to placebo group

  6 months

• Changes in Participant Pain Score (SF-MPQ-2)

  6 months

• Changes in participant function in daily life

  6 months

• Changes in menstrual symptom duration

  6 months

Study Arms (2)

Active Device

ACTIVE COMPARATOR

Device embedded with semiconductors

Device: Semiconductor embedded body sleeve

Placebo Device

PLACEBO COMPARATOR

Identical device absent of semiconductors

Device: Placebo Non-Compressive Body Sleeve

Interventions

Semiconductor embedded body sleeve DEVICE

The active device contains semiconductors embedded into the body sleeve fabric

Active Device

Placebo Non-Compressive Body Sleeve DEVICE

Identical body sleeve absent of semiconductors

Placebo Device

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Self-reported primary dysmenorrhea during past three menstrual cycles
• Age 18-45 inclusive at the time of consent
• Self-reported typical primary dysmenorrhea symptom pain greater than 4 on a 1-10 visual analog scale (VAS)
• History of regular menstrual cycles with a usual length of 21 to 35 days
• Willing and able to provide informed consent and adhere to study requirements

You may not qualify if:

• History of neurological conditions, including multiple sclerosis or Parkinson's disease
• Secondary dysmenorrhea including confirmed or suspected endometriosis or fibroids or intrauterine device
• Self-reported size not available in study device
• Pregnant or planning to become pregnant during the study
• Have within the past six months of enrollment, or are planning to in the next six months, start or discontinue any of the following contraceptive methods:
• intrauterine device
• oral contraceptives,
• contraceptive patch,
• implant (Nexplanon),
• shot (Depo-Provera),
• vaginal ring
• Chronic pain conditions unrelated to primary dysmenorrhea
• Auto-immune or auto-inflammatory diseases
• Has used within the last 90 days or is planning to use nicotine-containing products
• History of metabolic disorders

Sponsors & Collaborators

• University of California, Davis: lead
• INCREDIWEAR HOLDINGS, INC.: collaborator

MeSH Terms

Conditions

Dysmenorrhea

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

UC Davis Health Ob/Gyn Research

CONTACT

916-734-6846; obgynresearch@health.ucdavis.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 16, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03