CalmiGo for Anxiety and Panic Attacks

Overseen By Emery Hakim, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yves Duroseau

Disqualifiers: Asthma, COPD, Bipolar, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

35 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Currently, there are limited options in the management of anxiety and panic attack symptoms in the Emergency Department (ED). The most common treatment method is the use of anti-anxiety and anti-depressant medications; however, these drugs have serious health risks which make them ineffective as a long-term treatment option. The CalmiGo handheld device, formerly known as "myReLeaf", provides an alternative early intervention option in treating patients presenting with anxiety and panic attack symptoms by using guided breathing, aromatherapy, and grounding techniques. The hypothesis of this study is that CalmiGo will provide a drug-free, early intervention, and long-term treatment option in the ED that will improve patients' anxiety and panic attack symptoms. Patients who present to the ED with anxiety or panic attack symptoms will be considered eligible for this study. These patients will be approached, and they will give informed consent to participate in the study. Patients will be enrolled in the study which consists of completing validated surveys asking about their anxiety and panic symptoms, using CalmiGo, and allowing investigators to access their medical records. These surveys will be completed before and after using CalmiGo in the ED to measure the presence and severity of anxiety and panic symptoms. The goal of this study is to analyze the effectiveness of using CalmiGo to improve anxiety and panic attack symptoms based on validated survey responses. Overall, this study seeks to identify CalmiGo as an effective and alternative early intervention treatment option for patients presenting to the ED with anxiety or panic attack symptoms.

Who Is on the Research Team?

Yves Duroseau, MD

Principal Investigator

Lenox Hill Hospital

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Able to provide informed consent

Patients in the LHH Emergency Department (ED)

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

Exclusion Criteria

I have difficulty with thinking or memory.

I have been diagnosed with COPD.

I have a long-term lung condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Enrollment and Initial Assessment

Participants complete validated surveys assessing anxiety and panic symptoms and are introduced to the CalmiGo device

1 day

1 visit (in-person)

CalmiGo Device Use

Participants use the CalmiGo device under supervision and independently, followed by post-use surveys

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in anxiety and panic symptoms over time

1 year

What Are the Treatments Tested in This Trial?

Interventions

• CalmiGo

Trial Overview 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.

How Is the Trial Designed?

Group I: CalmiGo Recipients Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Yves Duroseau

Lead Sponsor

Trials

1

Recruited

40+

Dendro Technologies, Inc

Collaborator

Trials

1

Recruited

40+