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

NCT07353021 | Not Yet Recruiting

• 1 other identifier: 206-008
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety; Sleep

Keywords

Sleep; Stress; Anxiety

Outcome Measures

Primary Outcomes (1)

• General Anxiety Disorder 7 (GAD 7) Questionnaire

  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 Outcomes (1)

• Overal Anxiety Severity and Impairment Scale (OASIS) Questionnaire

  Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks

Other Outcomes (3)

• Warwick-Edinburgh Mental Wellbeing Scale

  Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks

• Wellness Questionnaire

  Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks

• Leeds Sleep Questionnaire

  Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks.

Study Arms (2)

Group 1

EXPERIMENTAL

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

Group 2

EXPERIMENTAL

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

Interventions

Active dermal patch DEVICE

Non-transdermal patch

Group 1

Placebo patch DEVICE

Non-transdermal patch

Group 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Natural Immune Systems Inc: lead

Study Sites (1)

NIS Labs

Klamath Falls, Oregon, 97601, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Gitte S Jensen, PhD

CONTACT

541 882 0112; Gitte@nislabs.com

Alex Cruickshank

CONTACT

Alex@nislabs.com

Study Design

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

Model Details: Randomized, double-blinded, placebo-controlled study design

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: January 20, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

US (1)