Longterm Effects of a Biofield Patch on Anxiety, Sleep, and Energy

January 13, 2026 updated by: Natural Immune Systems Inc

Clinical Trial on Long-Term Effects of a Biofield Patch on Anxiety, Sleep, and Energy. A Randomized Double-Blind Placebo-Controlled 4-week Trial.

The goal for this clinical trial is to compare an active biofield non-transdermal skin patch to a placebo patch in people who frequently experience anxiety.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The goal for this clinical trial is to document effects of a photobiomodulating non-transdermal patch compared to a placebo patch, in a randomized double-blind placebo-controlled design.

Data on stress and anxiety levels will be collected using the GAD and OASIS questionnaires as well as the Warwick-Edinburgh Mental Wellbeing Scales collected. The data collected will show whether the daily use of the patch leads to a change in general self-reported stress and anxiety levels. Data on energy levels will be collected using a Wellness questionnaire. Data on sleep quality will be collected using the Leeds sleep evaluation questionnaire, to document whether using the active patch impacts self-reported sleep.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Oregon
      • Klamath Falls, Oregon, United States, 97601
        • NIS Labs
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy adults of all genders;
  • Age 18-75 years (inclusive);
  • BMI between 18.0 and 34.9 (inclusive)

  • Experiencing intermittent episodes of anxiety on a regular basis, leading to either avoiding specific situations, or experiencing stress both in anticipation of, and during such situations.

    • Specific situations that occur regularly that cause anxiety, for example:

      • Performing specific tasks at work or at home;
      • Inter-personal conflicts at work or at home;
      • Driving or commuting;
      • Fearful and worrying about one's own situation (such as paying bills);
      • Worrying about ongoing problems experienced by others.

Exclusion Criteria:

  • Cancer during past 12 months;
  • Chemotherapy during past 12 months;
  • Currently taking anxiolytic, hypnotic, or anti-depressant prescription medication;
  • Currently taking nutritional supplements judged by the study coordinator to negate or camouflage the effects of the test product;
  • Participation in another clinical trial study during this trial, involving an investigational product or lifestyle change;
  • Serious active illness within past 6 months;
  • People who are pregnant, nursing, or trying to become pregnant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
Participants will use an active biofield patch daily for 4 weeks. The active biofield patch will look identical to a placebo patch, and will be blinded.
Device: Active dermal patch
Non-transdermal patch
Experimental: Group 2
Participants will use a placebo patch daily for 4 weeks. The placebo patch will look identical to an active patch, and will be blinded.
Device: Placebo patch
Non-transdermal patch

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
General Anxiety Disorder 7 (GAD 7) Questionnaire
Time Frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Change from baseline in anxiety score using the General Anxiety Disorder 7-item. The General Anxiety Disorder-7 scale evaluates anxiety severity using scores ranging from 0-21, where higher scores indicate higher anxiety severity.
Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overal Anxiety Severity and Impairment Scale (OASIS) Questionnaire
Time Frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Change from baseline in Overall Anxiety Severity and Impairment Scale (OASIS) score. The Overall Anxiety Severity and Impairment scale evaluates anxiety and impact on daily living in participants with a score between 0 and 25, where higher scores indicate higher anxiety severity and impact on daily living.
Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Warwick-Edinburgh Mental Wellbeing Scale
Time Frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Changes from baseline in mental wellbeing using the Warwick-Edinburgh Mental Wellbeing scale. The Warwick-Edinburgh Mental Wellbeing scale evaluates self reported happiness and satisfaction as well as psychological functioning, good relationships with others, and self realization.
Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Wellness Questionnaire
Time Frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Change from baseline in wellness evaluated using a Wellness questionnaire. The Wellness questionnaire consists of 30 questions, generating scores for physical, mental functioning, emotional wellbeing, stress, social functioning, sleep, and energy/vitality, where higher scores reflect better wellness.
Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Leeds Sleep Questionnaire
Time Frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks.
Changes from baseline in sleep quality. The Leeds Sleep Evaluation Questionnaire is a 10 item linear-log scale based on questions across several domains of sleep, where higher scores reflect better sleep quality
Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Natural Immune Systems Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

January 13, 2026

First Submitted That Met QC Criteria

January 13, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 13, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 206-008

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sleep

Clinical Trials on Active dermal patch

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo, DR of

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe