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Device

CPAP Therapy for Sleep Apnea

N/A
Recruiting
Led By Ali Azarbarzin, PhD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adults aged 21-80 years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study Summary

This trial is studying whether or not CPAP can help people with obstructive sleep apnea (OSA) by better characterizing OSA-related physiological consequences during sleep.

Who is the study for?
Adults aged 21-80 with moderate to severe obstructive sleep apnea (OSA) and an apnea-hypopnea index over 15 events/hr are eligible. They must not be currently treated for OSA, have uncontrolled medical issues, heart failure, renal insufficiency, neurological conditions affecting respiration, or use respiratory-depressing meds. Pregnant women and those with other sleep disorders or active non-prescription opioid use are excluded.Check my eligibility
What is being tested?
The trial is testing the effectiveness of Continuous Positive Airway Pressure (CPAP) in treating OSA by using new metrics to assess hypoxemia ('hypoxic burden'), autonomic response ('heart rate burden'), and sleep fragmentation ('arousal burden') rather than just the apnea-hypopnea index.See study design
What are the potential side effects?
While CPAP is generally safe, potential side effects include discomfort or irritation from the mask interface, dry nose or throat, nasal congestion, headaches, bloating and difficulty tolerating forced air.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 21 and 80 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline 24-hour mean systolic blood pressure at 12 weeks
Change from baseline Epworth Sleepiness Scale (ESS) at 12 weeks
Change from baseline flow-mediated vasodilation at 12 weeks
Secondary outcome measures
Change from baseline 24-hour mean blood pressure at 12 weeks
Change from baseline 24-hour mean diastolic blood pressure at 12 weeks
Change from baseline Albumin without Creatinine at 12 weeks
+19 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Positive Airway Pressure DeviceExperimental Treatment1 Intervention
All participants will receive PAP therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PAP
2016
N/A
~90

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,615 Previous Clinical Trials
11,470,672 Total Patients Enrolled
12 Trials studying Sleep Apnea
6,702 Patients Enrolled for Sleep Apnea
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,838 Previous Clinical Trials
47,851,496 Total Patients Enrolled
15 Trials studying Sleep Apnea
5,400 Patients Enrolled for Sleep Apnea
Ali Azarbarzin, PhDPrincipal Investigator - Brigham and Women's Hospital
Brigham and Women's Hospital

Media Library

PAP (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04575740 — N/A
Sleep Apnea Research Study Groups: Positive Airway Pressure Device
Sleep Apnea Clinical Trial 2023: PAP Highlights & Side Effects. Trial Name: NCT04575740 — N/A
PAP (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04575740 — N/A

Frequently Asked Questions

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

What are the targeted results of this investigation?

"The primary evaluation criterion of this trial, taking place over a period of 12 weeks, is the alteration in 24-hour mean systolic blood pressure. Additionally, there are three secondary objectives assessed: adjustment to fasting Fibrinogen Antigen levels (high values signify inflammation and increased risk for atherosclerosis), transformation in nocturnal mean systolic blood pressure calculated through ambulatory monitors, and shift from baseline Psychomotor Vigilance Task reaction time during 3-minute tests."

Answered by AI

Am I eligible to participate in this research study?

"This investigation is recruiting 158 people with sleep apnea syndromes aged 21 and 80. Notably, they must meet the following criteria: individuals aged between 21-80 years old, a prior diagnosis of moderate to severe obstructive sleep apnea, and an Apnoea–Hypopnea Index (AHI) higher than 15 events/hr during baseline study."

Answered by AI

How many volunteers are being accepted into this medical experiment?

"Affirmative. According to records on clinicaltrials.gov, the trial that was initiated on September 10th 2020 is actively looking for 158 volunteers from one medical location."

Answered by AI

Are there vacancies within this trial for volunteers?

"As per the information located on clinicaltrials.gov, this study is currently looking for participants to join. The initial post date was 10th of September 2020 and it has been updated as recently as 13th December 2021."

Answered by AI

Is this research program open to those aged 40 and above?

"The age range for inclusion in this study is 21 to 80. There are 42 studies catered towards people below the legal consenting age, and 205 trials designed to help those who have exceeded retirement age."

Answered by AI

Who else is applying?

What site did they apply to?
Brigham and Women's Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I want help and to help others.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Phenotyping Mechanistic Pathways for Adverse Health Outcomes in Sleep Apnea
Ali Azarbarzin 2020. "Phenotyping Mechanistic Pathways for Adverse Health Outcomes in Sleep Apnea". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04575740.
All > Apnea > Sleep Apnea
~7 spots leftby Jun 2024
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