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CalmiGo for Anxiety and Panic Attacks

N/A

Recruiting

Led By Yves Duroseau, MD

Research Sponsored by Yves Duroseau

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must be aged 18 years or older

Presenting with anxiety and panic attack symptoms (confirmed by ED provider)

Must not have

Cognitively impaired

Chief obstructive pulmonary disorder (COPD)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether the CalmiGo handheld device, which uses guided breathing, aromatherapy, and grounding techniques, can provide a drug-free, early intervention, and long-term treatment option in the ED that will improve patients' anxiety and panic attack symptoms.

Who is the study for?

This trial is for adults over 18 in the LHH Emergency Department who are experiencing anxiety or panic attacks, as confirmed by an ED provider. They must be able to give informed consent. It's not for those with cognitive impairments, pregnant women, minors, prisoners, or individuals with certain medical conditions like asthma, COPD, severe illnesses, substance abuse history, suicidal tendencies or chronic respiratory diseases.

What is being tested?

The CalmiGo handheld device is being tested as a drug-free treatment for anxiety and panic attack symptoms in the emergency setting. It uses guided breathing techniques combined with aromatherapy and grounding methods. The study involves patients using CalmiGo and completing surveys about their symptoms before and after its use.

What are the potential side effects?

Since CalmiGo is a non-pharmaceutical intervention involving guided breathing and aromatherapy without drugs involved there are no traditional side effects associated with its use; however individual experiences may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have been diagnosed with anxiety and panic attacks by an emergency department provider.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have difficulty with thinking or memory.

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I have been diagnosed with COPD.

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I have a history of seizures.

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I have asthma.

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I am under 18 years old.

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I have a severe illness that is not under control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in presentation and severity of anxiety and panic symptoms

Secondary study objectives

Anxiety

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: CalmiGo RecipientsExperimental Treatment1 Intervention

This arm will receive a CalmiGo handheld device during their participation in the study. Participants will first complete validated surveys assessing their anxiety and panic attack symptoms. Investigators will then demonstrate how to use the CalmiGo handheld device. Participants will use the device with the investigator and then participants will use the device on their own for at least 2 times. After using CalmiGo, participants will complete validated surveys reassessing their anxiety and panic attack symptoms, asking about their past medical history, and inquiring about their experience using CalmiGo.

0 / 8Eligibility criteria met