NeuroGlove Anxiety and Depression Study

Study Overview
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Brief Summary
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This is a prospective, homebased, interventional clinical study containing 10 subjects who will be enrolled. Approximately 10 (10) subjects with active anxiety and depression symptoms will receive treatment using the NeuroGlove.

Detailed Description
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This is a prospective, homebased, interventional clinical study containing 10 subjects who will be enrolled. Approximately 10 (10) subjects with active anxiety and depression symptoms will receive treatment using the NeuroGlove. Subjects will be recruited in from the community. Inclusion in the study will not impact the care management of the subject. Informed consent will be obtained from all subjects before inclusion in the study.

Official Title
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Impact of Peripheral Sensory Stimulation of the Hand and Synchronized Deep Breathing in the Treatment of Anxiety and Depression: Assessing Safety and Effectiveness

Conditions
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Anxiety, Depression, Anxiety Depression, Depression, Anxiety

Intervention / Treatment
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* Device: NeuroGlove


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to and willing to provide informed consent. Legally authorized representatives (LARs) will not be allowed to consent on behalf of the subject. Men and women ≥18 and <85 years of age. Carry an active diagnosis of anxiety and/or depression. Suffer from anxiety and/or depression symptoms that impact subject's daily activities and quality of life. Exclusion Criteria: Physical limitations of the upper extremity (e.g., fracture, joint deformity, severe spasticity/contracture, wounds, skin breakdown, lymphedema, etc.) The subject lacks the ability to comprehend or following instructions, or for any reason, in the opinion of the investigator, would be unlikely or unable to comply with study protocol requirements. Currently participating in another interventional clinical trial. (Observational clinical trial participation is allowed for study enrollment.)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NeuroGlove Treatment Arm<br>Subjects will receive treatment using the NeuroGlove. The treatment regimen at home will include 1 hour of therapy per day (two 30-minute sessions, one using each hand) for 4 weeks. | Device: NeuroGlove<br>* The NeuroGlove is intended to provide peripheral sensory stimulation to the hand through pneumatic puffs of air to encourage collateral blood supply and sensorimotor development.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in anxiety symptoms using GAD-7 | The change in symptoms pertaining to anxiety will be evaluated using the change in the GAD-7 score. The GAD-7 is a general anxiety questionnaire with 7 questions. The score ranges from 0 - no anxiety to 21 - severe anxiety. | 4 weeks | 
| Change in depression symptoms using PHQ-9 | The change in symptoms pertaining to depression will be evaluated using the change in the PHQ-9 score. The PHQ-9 is a general anxiety questionnaire with 9 questions. What does a PHQ-9 score mean? Scores less than 5 often signify the absence of a depressive disorder; scores of 5 to 9 predominantly represented patients with either no depression; depression scores of 10 to 14 represented a spectrum of patients; and scores of 15 or greater usually indicated major depression. | 4 weeks | 
| Rate of Adverse Events | Rate and severity of adverse events related to the use of the NeuroGlove assessed by PI during patient interview. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety, Depression