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

NCT07353021 — Not applicable, Not yet recruiting, 40 participants, Natural Immune Systems Inc

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

RegistryNCT07353021
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: double, basic science
Enrollment40 (Estimated)
SponsorNatural Immune Systems Inc (Other)
ConditionsAnxiety, Sleep
InterventionsActive dermal patch, Placebo patch (Device)
Datesstart 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
Locations1 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

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Group 1ExperimentalDevice: Active dermal patchParticipants 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 2ExperimentalDevice: Placebo patchParticipants will use a placebo patch daily for 4 weeks. The placebo patch will look identical to an active patch, and will be blinded.
  • Active dermal patch (Device): Non-transdermal patch
  • Placebo patch (Device): Non-transdermal patch

+Outcome measures

Primary outcomes

  • General Anxiety Disorder 7 (GAD 7) Questionnaire [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.

Secondary outcomes

  • Overal Anxiety Severity and Impairment Scale (OASIS) Questionnaire [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.

Other outcomes

  • Warwick-Edinburgh Mental Wellbeing Scale [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.
  • Wellness Questionnaire [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.
  • Leeds Sleep Questionnaire [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

+Eligibility

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.

+Locations (1)

FacilityCityCountryStatus
NIS LabsKlamath Falls, OregonUnited States