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NCT Number: NCT07353021

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

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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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Active dermal patch

Device

Non-transdermal patch

Placebo Patch

Device

Non-transdermal patch

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Alex Cruickshank

CONTACT

[email protected]

Gitte S Jensen, PhD

CONTACT

[email protected]

541 882 0112

Sponsors and collaborators

Lead sponsor

Natural Immune Systems Inc

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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