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Auricular Laser Acupuncture for Sleep in Breast Cancer Patients

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Summary

NCT07547423 is a randomized controlled trial registered on ClinicalTrials.gov evaluating whether active auricular laser acupuncture improves sleep quality and reduces insomnia severity compared to a sham control in female breast cancer patients aged 18 to 75 with insomnia. The trial involves 10 sessions of laser treatment (active or sham) administered twice weekly over 5 weeks, with participants wearing protective goggles to maintain blinding, using actigraphy wristbands, sleep diaries, and heart rate variability measurements at baseline and Week 5.

“The goal of this clinical trial is to learn if auricular laser acupuncture can improve sleep quality and alleviate related symptoms in female breast cancer patients aged 18 to 75 with insomnia.”

NIH , verbatim from source
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About this source

ClinicalTrials.gov is the NIH-run registry of every clinical trial conducted in the United States, plus most international trials sponsored by US-based companies or institutions. By federal law, sponsors must register Phase 2 through Phase 4 studies before enrolling patients and post results within a year of completion. This feed tracks every new trial registration and study update, around 700 a month: drug interventions, device studies, behavioral protocols, observational research. Watch this if you scout drug candidates moving into mid or late-stage development, monitor competitor pipelines, or follow rare disease research where new trials signal patient hope. GovPing parses sponsor, phase, intervention, and target indication on each entry.

What changed

A new clinical trial registration (NCT07547423) has been posted on ClinicalTrials.gov describing a randomized, sham-controlled study evaluating auricular laser acupuncture for sleep improvement in female breast cancer patients with comorbid insomnia. The trial plans to enroll participants aged 18-75, who will receive 10 treatment sessions over 5 weeks while blinded, with primary outcomes assessed via actigraphy and validated sleep questionnaires at Week 5 and follow-up at Week 10. As a registry entry, this document does not impose compliance obligations; it serves as a public record of the trial design and recruitment parameters.

Healthcare institutions and clinical investigators conducting oncology or sleep-medicine research should note the study's methodology, including the sham-controlled design, blinding procedures (protective goggles), and use of heart rate variability as a secondary endpoint. Sponsors of competing or complementary trials in cancer-related insomnia should review the inclusion criteria and outcome measures to assess overlap or differentiation opportunities.

Archived snapshot

Apr 24, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

← ClinicalTrials.gov Studies

Auricular Laser Acupuncture for Improving Sleep in Breast Cancer Patients

N/A NCT07547423 Kind: NA Apr 23, 2026

Abstract

The goal of this clinical trial is to learn if auricular laser acupuncture can improve sleep quality and alleviate related symptoms in female breast cancer patients aged 18 to 75 with insomnia. The main questions it aims to answer are:

  1. Does active auricular laser acupuncture improve sleep quality and reduce the severity of insomnia?
  2. Does it help lower levels of cancer-related fatigue, anxiety, and depression?

Researchers will compare an active auricular laser acupuncture group to a sham control group (receiving no therapeutic laser energy) to see if active laser acupuncture is effective for symptom relief.

Participants will:

  1. Receive 10 sessions of laser treatment (active or sham) twice a week for 5 weeks, while wearing protective goggles to ensure blinding.
  2. Wear an actigraphy wristband and keep a sleep diary to monitor sleep patterns, and undergo heart rate variability (HRV) measurements at baseline and Week 5 (post-treatment).
  3. Complete questionnaires assessing sleep, fatigue, mood, and quality of life at baseline, Week 5 (post-treatment), and Week 10 (follow-up).

Conditions: Breast Cancer Females, Insomnia

Interventions: auricular laser acupuncture, sham auricular laser acupuncture

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Classification

Agency
NIH
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Healthcare providers Patients Clinical investigators
Industry sector
6211 Healthcare Providers
Activity scope
Clinical trial registration Medical research Cancer treatment study
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Topics
Pharmaceuticals Medical Devices

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