CalmiGo for Anxiety and Panic Attacks

YD
Kv
RT
EH
Overseen ByEmery Hakim, BS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Yves Duroseau
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a device called CalmiGo, which provides a drug-free method to assist individuals with anxiety and panic attacks in the Emergency Department (ED). The device employs guided breathing, aromatherapy, and grounding techniques to quickly and safely alleviate symptoms. The researchers aim to determine if CalmiGo can serve as a viable alternative to medication for those frequently visiting the ED due to anxiety or panic attacks. Individuals experiencing anxiety or panic attacks in the ED who can provide consent may be suitable for this study. Participants will use the device and complete surveys about their symptoms before and after using CalmiGo. As an unphased trial, this study offers participants the chance to explore a new, non-medication approach to managing anxiety and panic attacks.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on using the CalmiGo device as an alternative treatment for anxiety and panic attacks.

What prior data suggests that the CalmiGo device is safe for treating anxiety and panic attacks?

Research has shown that CalmiGo provides a safe, drug-free method for managing anxiety and panic attacks. It employs guided breathing, aromatherapy, and grounding techniques to help users relax, avoiding the side effects often associated with medication.

The CalmiGo device is currently available for managing stress and panic attacks. Users report that it is easy to use and effective in calming them during stressful times. No major negative effects have been reported. However, as a device rather than a medication, its safety undergoes a different assessment process.

Although clinical trial data specifically on its safety may be limited, its availability for stress management suggests it is generally safe. Anyone considering participation in a clinical trial should consult their healthcare provider to ensure it is appropriate for them.12345

Why are researchers excited about this trial?

Unlike traditional treatments for anxiety and panic attacks, which often involve medication or talk therapy, CalmiGo offers a drug-free, handheld device solution. This device uses a combination of personalized breathing regulation, calming scents, and multi-sensory stimulation to help manage symptoms quickly. Researchers are excited about CalmiGo because it provides an immediate, on-the-go option that empowers users to gain control over their anxiety and panic attacks anytime, anywhere. This novel approach not only offers a potentially faster response than traditional treatments but also minimizes side effects associated with medication.

What evidence suggests that the CalmiGo device is effective for anxiety and panic attacks?

Studies have shown that CalmiGo can significantly reduce anxiety, PTSD, stress, worry, and burnout. It guides users through breathing exercises, uses calming scents, and helps focus on the present moment. Research indicates that CalmiGo provides relief in about three minutes, faster than some traditional medications. This makes it a promising option for quick relief from anxiety and panic attacks. Overall, early findings suggest that CalmiGo effectively manages anxiety without medication side effects. Participants in this trial will receive a CalmiGo handheld device to assess its effectiveness in reducing anxiety and panic attack symptoms.16789

Who Is on the Research Team?

YD

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.
See 11 more

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?
1Treatment groups
Experimental Treatment
Group I: CalmiGo RecipientsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Yves Duroseau

Lead Sponsor

Trials
1
Recruited
40+

Dendro Technologies, Inc

Collaborator

Trials
1
Recruited
40+

Citations

Using CalmiGo to Manage Anxiety and Panic Attack ...Overall, this study seeks to identify CalmiGo as an effective and alternative early intervention treatment option for patients presenting to the ED with anxiety ...
Clinical studiesCalmIGo's efficacy has been validated in a number of independent trials that showed a significant reduction in anxiety, PTSD, stress, worry, and burnout ...
TTR and TTCI as New Industry Metrics for Evaluating Time- ...CalmiGo's Performance · A. TTR: Fastest Time to Relief · CalmiGo: ~3 min · Benzodiazepines: 15–30 min · SSRIs: Days–weeks · Meditation Apps: 10–15 min (after ...
CalmiGo for Anxiety and Panic Attacks · Info for ParticipantsOverall, this study seeks to identify CalmiGo as an effective and alternative early intervention treatment option for patients presenting to the ED with ...
Clinical Studies Showed EfficacyCalmIGo's efficacy has been validated in a number of independent trials that showed a significant reduction in anxiety, PTSD, stress, worry, ...
CalmiGoCalmiGo is a patented technology-based device that provides immediate drug-free relief in moments of anxiety, stress, and panic attacks.
FSA Eligible CalmiGo Smart Calming DeviceThis clinically validated, scientifically proven device provides rapid relief from anxiety, panic attacks, and PTSD symptoms while supporting long-term mental ...
CalmiGo (Gen-1) Immediate Anxiousness & Stress Relief ...Customers find the calming device effective at helping them relax and refocus, particularly during panic attacks. Moreover, the device is easy to use.
SSRIs: Their Use, Side Effects, and Withdrawal SymptomsCalmiGo is a scientifically proven stress reduction tool that incorporates smell, sight, touch, and breathing into an effective and proven grounding technique.
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