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OSA Treatment for Sleep Apnea (ESSENTIAL Trial)

Q: Is this experiment enlisting participants who exceed the age of fifty-five?

This trial exclusively accepts participants aged between 55 and 75 years old.

Q: Are new participants being onboarded for this research endeavor?

Inferring from the clinicaltrials.gov database, this research project is currently not open to new enrolment; its initial posting was on January 1st 2024 with a last update of August 4th 2023. Nevertheless, 870 other studies are still actively hunting for participants at the present time.

Q: Is enrollment available for me to partake in this clinical trial?

This clinical trial is offering enrollment to adults aged 55-75 who have been diagnosed with obstructive <a href="https://www.withpower.com/clinical-trials/sleep-apnea">sleep apnea</a>. There are currently 250 spaces available for this study.

Q: What outcomes is this trial aiming to ascertain?

This 24-month investigation seeks to evaluate the alteration of Aβ42/Aβ40 ratio. Secondary objectives include an examination of shifts in task switching median reaction time (milliseconds), variance in Psychomotor Vigilance Task lapses, and fluctuation in PVT response latency (measured as mean milliseconds).

N/A

Waitlist Available

Led By Andrew Varga, MD

Research Sponsored by California Pacific Medical Center Research Institute

Eligibility Criteria Checklist

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

Must have

Moderate - severe OSA defined as AHI4 ≥20 events/hour or AHI3A>40/hr using a Hypopnea criterion of a 4% oxygen desaturation (AHI4) or 3% oxygen desaturation and/or EEG arousal (AHI3A)

No OSA treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

ESSENTIAL Trial Summary

This trial will investigate if successful treatment of OSA in older adults improves memory & biomarkers associated with Alzheimer's.

Who is the study for?

This trial is for adults aged 55-75 with moderate to severe obstructive sleep apnea (OSA), who are cognitively normal, have at least a high school education, and can speak English or Spanish. They shouldn't be on OSA treatment already or have other sleep disorders, significant brain vascular damage, serious health issues, drug abuse history, or be taking certain medications affecting cognition.Check my eligibility

What is being tested?

The ESSENTIAL study tests if treating OSA in older adults improves memory and Alzheimer's disease biomarkers. Participants will either receive immediate OSA treatment using PAP, oral appliances or positional therapy for three months or be placed on a waitlist control group with later treatment. Both groups are followed up for two years.See study design

What are the potential side effects?

While the trial doesn't specify side effects of treatments directly, common ones may include discomfort from devices used in PAP and oral appliance therapies like dry mouth/nose/throat, nasal congestion and possible soreness.

ESSENTIAL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have moderate to severe sleep apnea with significant breathing pauses.

Select...

I am not receiving treatment for sleep apnea.

Select...

I am between 55 and 75 years old.

ESSENTIAL Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months 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 in Aβ42/ Aβ40 ratio

Change in Neurofibrilary light (NfL)

Change in P-tau217

+3 more

Secondary outcome measures

Change in Psychomotor Vigilance Task (PVT) lapses

Change in Psychomotor Vigilance Task (PVT) reaction time

Change in Task-switching Accuracy

+1 more

Other outcome measures

Clinical Dementia Rating (CDR) Scale (0-3)

Cognitive Impairment Severity

Insomnia Severity

+4 more

ESSENTIAL Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Waitlist control groupExperimental Treatment3 Interventions

A waitlist control group to receive treatment at the conclusion of the 3-month intervention period.

Group II: 3-month OSA treatmentActive Control3 Interventions

A 3-month OSA treatment by any combination of PAP, OAT, and positional therapy that results in an "effective" AHI3a<15 (rapid multi-modal treatment RMMT).

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of ArizonaOTHER

514 Previous Clinical Trials

148,071 Total Patients Enrolled

University of PittsburghOTHER

1,719 Previous Clinical Trials

16,342,141 Total Patients Enrolled

National Institute on Aging (NIA)NIH

1,671 Previous Clinical Trials

28,016,813 Total Patients Enrolled

Media Library

Oral appliance therapy (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05988385 — N/A

Obstructive Sleep Apnea Research Study Groups: 3-month OSA treatment, Waitlist control group

Obstructive Sleep Apnea Clinical Trial 2023: Oral appliance therapy Highlights & Side Effects. Trial Name: NCT05988385 — N/A

Oral appliance therapy (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05988385 — 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 experiment enlisting participants who exceed the age of fifty-five?

"This trial exclusively accepts participants aged between 55 and 75 years old."

Answered by AI

Are new participants being onboarded for this research endeavor?

"Inferring from the clinicaltrials.gov database, this research project is currently not open to new enrolment; its initial posting was on January 1st 2024 with a last update of August 4th 2023. Nevertheless, 870 other studies are still actively hunting for participants at the present time."

Answered by AI

Is enrollment available for me to partake in this clinical trial?

"This clinical trial is offering enrollment to adults aged 55-75 who have been diagnosed with obstructive sleep apnea. There are currently 250 spaces available for this study."

Answered by AI

What outcomes is this trial aiming to ascertain?

"This 24-month investigation seeks to evaluate the alteration of Aβ42/Aβ40 ratio. Secondary objectives include an examination of shifts in task switching median reaction time (milliseconds), variance in Psychomotor Vigilance Task lapses, and fluctuation in PVT response latency (measured as mean milliseconds)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study

2024. "The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05988385.