Anxiety, Sleep
Conditions
Keywords
Sleep, Stress, Anxiety
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.
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.
Interventions
DEVICEActive dermal patch
Non-transdermal patch
DEVICEPlacebo patch
Non-transdermal patch
Sponsors
Natural Immune Systems Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Randomized, double-blinded, placebo-controlled study design
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTGitte S Jensen, PhD
CONTACTAlex Cruickshank
Outcome results
None listed