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Device

Nifedipine 30 MG for CPAP

N/A

Waitlist Available

Led By Todd Bolotin, MD

Research Sponsored by Centura Health

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 hours

Awards & highlights

Study Summary

This trial is testing if positive pressure can help with high-altitude pulmonary edema, and if ultrasound can show B lines in the lungs after 2 hours.

Eligible Conditions

CPAP
High Altitude Pulmonary Edema

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time to resolution of HAPE

Secondary outcome measures

Characterization of time at altitude to development of HAPE

Incidence of HAPE by native altitude and reported sleeping altitude

Presence or absence of ultrasound detectable B lines

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Experimental: CPAPExperimental Treatment2 Interventions

Participants will be treated with CPAP. All patients will be treated with nifedipine unless there is a contraindication like hypotension and bradycardia.

Group II: Control: High flow oxygenPlacebo Group2 Interventions

Participants will be treated with an altered CPAP mask that will deliver high flow oxygen. All patients will be treated with nifedipine unless there is a contraindication like hypotension and bradycardia.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CPAP mask system

2020

N/A

~70

Nifedipine 30 MG

2023

Completed Phase 4

~180

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Centura HealthLead Sponsor

7 Previous Clinical Trials

120 Total Patients Enrolled

Pulmodyne, Inc.UNKNOWN

Todd Bolotin, MD2.33 ReviewsPrincipal Investigator - Centura Health

Centura Health

2 Previous Clinical Trials

225 Total Patients Enrolled

1Patient Review

I had a very brief and unenlightening interaction with Dr. Bolotin in the ER at St. Elizabeth's. He was inaccurate and rude, and I am extremely grateful that Dr. Huang was the one who saw me through my treatment. I would be very upset if I received a bill for Dr. Bolotin's services.

Media Library

CPAP mask system (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04186598 — N/A

CPAP Research Study Groups: Experimental: CPAP, Control: High flow oxygen

CPAP Clinical Trial 2023: CPAP mask system Highlights & Side Effects. Trial Name: NCT04186598 — N/A

CPAP mask system (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04186598 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this a pioneering research endeavor?

"Currently, 11 trials pertaining to Nifedipine 30 MG are being conducted across 62 cities and 5 countries. This medication was originally trialled in 2007 by Encysive Pharmaceuticals with 27 patients involved reaching Phase 2 of drug approval. Since then, 68 studies have been completed."

Answered by AI

Is Nifedipine 30 MG being tested in trials elsewhere?

"Currently, 11 trials are actively researching Nifedipine 30 MG with 3 of those at the final stage. Breckenridge, Colorado is one site running a study but there exists an additional 85 locations participating in studies related to this medication."

Answered by AI

How many participants is this clinical trial currently recruiting?

"Affirmative. Clinicaltrials.gov documents the fact that this clinical trial is proactively recruiting, having first been posted on January 20th of 2020 and most recently edited on July 18th 2022. This medical research requires 264 patients to be recruited from a single centre."

Answered by AI

What indications is Nifedipine 30 MG most generally prescribed for?

"Nifedipine 30 MG is often prescribed to ameliorate vasospastic angina, but can also prove beneficial in treating premature labour and other effects of high altitude as well as achalasia."

Answered by AI

Does this investigation presently require participants?

"Affirmative. Per the details on clinicaltrials.gov, this trial is currently enlisting patients and was initially announced in January of 2020. The latest amendment to the study occured in July 2022 with a target of 264 participants from one single medical facility."

Answered by AI

Recent research and studies

Wilderness & Environmental MedicineJournal

Wilderness Medical Society Clinical Practice Guidelines for the Prevention and Treatment of Acute Altitude Illness: 2019 Update

Luks, Andrew M., Paul S. Auerbach, Luanne Freer, Colin K. Grissom, Linda E. Keyes, Scott E. McIntosh, George W. Rodway, Robert B. Schoene, Ken Zafren, and Peter H. Hackett. 2019. “Wilderness Medical Society Clinical Practice Guidelines for the Prevention and Treatment of Acute Altitude Illness: 2019 Update”. Wilderness & Environmental Medicine. Elsevier BV. doi:10.1016/j.wem.2019.04.006.

High Altitude Medicine & BiologyJournal

Continuous Positive Airway Pressure Treatment for Acute Mountain Sickness at 4240 M in the Nepal Himalaya

Johnson, Pamela L., Claire C. Johnson, Prasanta Poudyal, Nirajan Regmi, Megan A. Walmsley, and Buddha Basnyat. 2013. “Continuous Positive Airway Pressure Treatment for Acute Mountain Sickness at 4240 M in the Nepal Himalaya”. High Altitude Medicine & Biology. Mary Ann Liebert Inc. doi:10.1089/ham.2013.1015.

Current Infectious Disease ReportsJournal

Prevention and Treatment of High-altitude Illness in Travelers

Murdoch, David R.. 2004. “Prevention and Treatment of High-altitude Illness in Travelers”. Current Infectious Disease Reports. Springer Science and Business Media LLC. doi:10.1007/s11908-004-0023-4.

Emergency Medicine Clinics of North AmericaJournal