Panic DisorderNCT03360578
Measuring Physiology to Determine if Pre-panic Attack Detection is Possible
An observational study of Panic Disorder, run by Medical Psychology Center at 1 site in United States.
Trial summary
Participants will be asked to wear a physiological monitoring device for 1 week and record when panic events occur. Once the device is returned, the data will be downloaded and analyzed. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Panic Disorder
- What is being tested?
- Garmin
- Type of treatment
- Medical device
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: 18-65 individuals with panic disorder that are mentally capable to consent and are not pregnant
Who may be able to join
- Panic disorder as described in the Diagnostic and Statistical Manual - 5 (DSM-5)
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Medical Psychology Center
Beverly, Massachusetts, 01915
Jonathan Inz, PhD
About this study
Official title: Measuring Physiology in Individuals With Panic Disorder to Determine if Panic Attack Detection is Possible
Participants will be asked to wear a physiological monitoring device for 1 week and record when panic events occur. Once the device is returned, the data will be downloaded and analyzed.
- Conditions
- Panic Disorder
- Being tested
- Garmin
- Medical subject headings
- Panic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GarminDevice
A commercial grade health wearable
What is being measured
The primary outcome is the main question the study is designed to answer.
Panic event
A timestamp of when a panic attack occurred
Measured: 1 year
Heart Rate
Beats per minute
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study start1 Oct 2018
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Panic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Psychology Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03360578
- Sponsor's protocol ID
- Pre-Panic Physiology
- Status last verified
- Apr 2022
- First submitted
- 22 Nov 2017
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Physiology in Individuals With Panic Disorder to Determine if Panic Attack Detection is Possible
- ClinicalTrials.gov ID
- NCT03360578
- Acronym / sponsor ID
- Pre-Panic Physiology
- Conditions
- Panic Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Medical Psychology CenterUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 4 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Participants will be asked to wear a physiological monitoring device for 1 week and record when panic events occur. Once the device is returned, the data will be downloaded and analyzed.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 18-65 individuals with panic disorder that are mentally capable to consent and are not pregnant
Key inclusion criteria (1 listed)
- Panic disorder as described in the Diagnostic and Statistical Manual - 5 (DSM-5)
Key exclusion criteria (1 listed)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GarminA commercial grade health wearable | Device | – |
Primary outcome
Panic event
Time frame: 1 year
A timestamp of when a panic attack occurred
Heart Rate
Time frame: 1 year
Beats per minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Panic Disorder, run by Medical Psychology Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Inz, PhD (978-921-4000 ext. 10, jinz@mpc.care), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Panic event (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2022.