CPAP for Sleep Apnea Syndromes

1
Effectiveness
1
Safety
Yale-New Haven Hospital, New Haven, CT
Sleep Apnea Syndromes+11 More
CPAP - Device
Eligibility
18+
All Sexes
Eligible conditions
Sleep Apnea Syndromes

Study Summary

This study is evaluating whether a treatment for sleep apnea may help reduce the risk of stroke.

See full description

Eligible Conditions

  • Sleep Apnea Syndromes
  • Apnea
  • Sleep Apnea, Obstructive
  • Stroke
  • Wake-up Stroke
  • Home Sleep Apnea Test
  • Continuous Positive Airway Pressure (CPAP)
  • Randomized Clinical Trial
  • Transient Ischemic Attack
  • Sleep Apnea
  • Multicenter Trial
  • Telemedicine
  • Ischemic Stroke

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether CPAP will improve 2 primary outcomes and 3 secondary outcomes in patients with Sleep Apnea Syndromes. Measurement will happen over the course of 3 months post randomization.

3 months post randomization
Modified Rankin Scale Score
NIH Stroke Score (NIHSS)
Quality of Life outcome
Short Montreal Cognitive Assessment (MoCA) Score
6 months post randomization
Time to Event Combined Outcome: new ischemic stroke, acute coronary syndrome, or all-cause mortality

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
Intervention Arm: CPAP with Usual Care.

This trial requires 3062 total participants across 2 different treatment groups

This trial involves 2 different treatments. CPAP is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Intervention Arm: CPAP with Usual Care.
Device
6 months of CPAP plus usual medical therapy.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CPAP
2013
Completed Phase 4
~3690

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months post randomization
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6 months post randomization for reporting.

Who is running the study

Principal Investigator
D. L. B.
Prof. Devin L. Brown, MD
University of Michigan

Closest Location

Yale-New Haven Hospital - New Haven, CT

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Sleep Apnea Syndromes or one of the other 11 conditions listed above. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
1. TIA with ABCD2 ≥4 or ischemic stroke, within the prior 14 days.

Patient Q&A Section

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

Does sleep apnea syndromes run in families?

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OSA2 and snoring are highly heritable and run in families. The findings suggest that the OSA2 phenotype may be modulated by genes at two different loci.

Unverified Answer

What are the signs of sleep apnea syndromes?

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The signs of obstructive [sleep apnea](https://www.withpower.com/clinical-trials/sleep-apnea) include snoring, excessive daytime sleepiness, insomnia, and the repetitive episodes of apneas and hypopneas. These signs are easily noticed by health professionals, however, patients often assume otherwise. Untreated sleep apnea can result in hypertension, sleep paralysis, and sleep disturbances that can worsen cardiovascular morbidity and mortality.

Unverified Answer

How many people get sleep apnea syndromes a year in the United States?

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Every year, around 60 million Americans will meet diagnostic criteria for [sleep apnea](https://www.withpower.com/clinical-trials/sleep-apnea) syndrome (asthma with airflow obstruction and narcolepsy with excessive daytime sleepiness). About 11% of this population has severe sleep apnea and will seek treatment.

Unverified Answer

What causes sleep apnea syndromes?

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There are many possible causes of sleep deprivation that may lead to the development of sleep apnea. The mechanisms involve excessive muscular activities and poor jaw control. In particular, there are some environmental issues that may cause sleep apnea; such as a sudden change to the environment, excessive drinking, or shift work. In addition to these issues mentioned, there is a gene connection, and that is the biggest factor in these sleep apnea syndromes. At the end of the 20th century, the genetic issue was confirmed through various studies. The gene is called "obstructive sleep apnea hypopnea". The research showed that in the early years of my sleep studies, I did a lot of my work for 5 days each week.

Unverified Answer

What is sleep apnea syndromes?

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Sleep apnea syndromes are usually unrecognized and usually remain asymptomatic despite significant morbidity. They can present as a range of complaints from insomnia to daytime somnolence to airway obstruction. Sleep testing can be performed in order to confirm the diagnosis and manage the airway and breathing disorders. We will discuss the clinical presentation, pathophysiology, and available workup. We will discuss the clinical evaluation and diagnostics required to confirm the diagnosis of [sleep apnea](https://www.withpower.com/clinical-trials/sleep-apnea) and discuss its treatment options from lifestyle improvements to the use of continuous positive nasal airway pressure (CPAP).

Unverified Answer

Can sleep apnea syndromes be cured?

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Obstructive sleep apnea must be treated with continuous positive airway pressure or adenotonsillectomy to ameliorate CPAP's efficacy. CPAP does not appear to be effective for treating nasal congestion.

Unverified Answer

What are common treatments for sleep apnea syndromes?

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Treatment of OSA is highly individualized. Most patients take one or more medications. There are several different options of treatment including continuous positive airway pressure therapy (CPAP) and oral appliances. CPAP therapy has been effective for many years and was generally better tolerated than oral appliances in a large multicenter survey of sleep apnea patients.

Unverified Answer

What are the latest developments in cpap for therapeutic use?

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The CPAP algorithm used in the United States has been modified to account for demographics and comorbidities of the patient population with therapeutic uses of CPAP.

Unverified Answer

Have there been other clinical trials involving cpap?

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There are no clinical trials or cohort studies to support the notion that cpap therapy does not prevent obstructive airway events in patients with sleep apnea syndrome and normal lung function.

Unverified Answer

Who should consider clinical trials for sleep apnea syndromes?

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Among the patients with moderate to severe OSA, both the male and female patients are less likely to be interested in clinical trials for CPAP. However, both cohorts are similarly interested in CPAP trials for OSA syndromes.

Unverified Answer

Does cpap improve quality of life for those with sleep apnea syndromes?

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Subjects with OSA demonstrated improvement in subjective and objective markers of sleepiness. Cpap led to marked improvements in CPIS scores, subjective sleepiness, cognitive performance, and ESSD in OSA patients.

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How serious can sleep apnea syndromes be?

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Patients with all forms of OSASs can have an increased risk for severe complications such as carotid plaques, stroke, and death. Some can have decreased heart rates and blood pressure, whereas others can have a decrease in cognitive ability and impaired driving. If you suspect you have a sleep apnea condition, consult your doctor.

Unverified Answer
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