Clinical Trial on Long-Term Effects of a Biofield Patch on Anxiety, Sleep, and Energy. A Randomized Double-Blind Placebo-Controlled 4-week Trial.
| Registry | NCT07353021 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, basic science |
| Enrollment | 40 (Estimated) |
| Sponsor | Natural Immune Systems Inc (Other) |
| Conditions | Anxiety, Sleep |
| Interventions | Active dermal patch, Placebo patch (Device) |
| Dates | start 2026-01-01 (estimated), primary completion 2026-12-01 (estimated), completion 2027-03-01 (estimated), first posted 2026-01-20, last updated 2026-01-20 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Anxiety All trials for Sleep All trials of Active dermal patch All trials of Placebo patch
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Group 1 | Experimental | Device: Active dermal patch | 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. |
| Group 2 | Experimental | Device: Placebo patch | Participants will use a placebo patch daily for 4 weeks. The placebo patch will look identical to an active patch, and will be blinded. |
Sex: All, ages: 18 Years to 75 Years, accepts healthy volunteers
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.| Facility | City | Country | Status |
|---|---|---|---|
| NIS Labs | Klamath Falls, Oregon | United States |