AnxietyNCT07353021
Longterm Effects of a Biofield Patch on Anxiety, Sleep, and Energy
A study testing Active dermal patch in people with Anxiety and Sleep, run by Natural Immune Systems Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- What is being tested?
- Active dermal patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alex Cruickshank contact
United States1 site
NIS Labs
Klamath Falls, Oregon, 97601
Gitte S. Jensen, PhD, 5418840112, gitte@nislabs.com
About this study
Official 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.
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.
Read the 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.
- Being tested
- Active dermal patch, Placebo patch
- Keywords
- Sleep, Stress, Anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active dermal patchDevice
Non-transdermal patch
Placebo patchDevice
Non-transdermal patch
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Placebo patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Secondary outcomes (1)
Overal Anxiety Severity and Impairment Scale (OASIS) Questionnaire
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.
Measured: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blinded, placebo-controlled study design
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Natural Immune Systems Inc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07353021
- Sponsor's protocol ID
- 206-008
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2026
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07353021
- Acronym / sponsor ID
- 206-008
- Keywords
- Sleep, Stress, Anxiety
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Natural Immune Systems IncUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blinded, placebo-controlled study design
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: 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 2 | Experimental | Device: 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active dermal patchNon-transdermal patch | Device | Group 1 |
| Placebo patchNon-transdermal patch | Device | Group 2 |
Primary outcome
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.
1 secondary outcome
Overal Anxiety Severity and Impairment Scale (OASIS) Questionnaire
Time frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alex Cruickshank contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active dermal patch in people with Anxiety and Sleep, run by Natural Immune Systems Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gitte S Jensen, PhD (541 882 0112, Gitte@nislabs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General Anxiety Disorder 7 (GAD 7) Questionnaire (time frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.