BridgeMD
New treatment option for Obstructive Sleep Apnea
Official title The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study
ClinicalTrials.gov ID: NCT05988385
What this study is testing
- What it's testing
- The Effects of Successful OSA TreatmENT on Memory and AD BIomarkers in Older AduLts (ESSENTIAL) study is a 5-year, multicenter randomized open-label trial that will screen 400 cognitively normal older adults recruited from well-established sleep clinics at 4 academic medical centers, with newly diagnosed moderate-severe OSA. An expected 200 OSA patients will be then randomized to one of two groups: i) a 3-month OSA treatment by any combination of PAP, OAT, and positional therapy that results in an "effective" AHI4%\< 10/hour and AHI3A\<20/hour (see below); ii) a waitlist control group to receive treatment at the conclusion of the 3-month intervention period.
- Time commitment: about 24 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 to 85
You may be able to join if
- Cognitively normal (TiCS ≥29)
- Age 55-85 years
- 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...
- Not currently on therapy for OSA and has not received treatment for OSA for at least 6months
- Able and willing to be treated for OSA (Treatment group)
You likely can't join if
- Documented diagnosis of chronic insomnia, or sleep onset insomnia based on Insomnia Severity Index - a answer of severe or very severe in the...
- Documented diagnosis of circadian rhythm disorder
- Any current use of supplemental oxygen
- Other sleep-related breathing disorders (central sleep apnea, etc) based on AASM criteria
- Current shift work involving night shift (regular work between 12am and 6am or night shift) within the past 6 mo
- Anticipated scheduled bariatric surgery within the next 3 months
See the full eligibility criteria
- Cognitively normal (TiCS ≥29)
- Age 55-85 years
- 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), or equivalent based on in-home...
- Not currently on therapy for OSA and has not received treatment for OSA for at least 6months
- Able and willing to be treated for OSA (Treatment group)
- Fluency in English or Spanish
- Documented diagnosis of chronic insomnia, or sleep onset insomnia based on Insomnia Severity Index - a answer of severe or very severe in the screening form
- Documented diagnosis of circadian rhythm disorder
- Any current use of supplemental oxygen
- Other sleep-related breathing disorders (central sleep apnea, etc) based on AASM criteria
- Current shift work involving night shift (regular work between 12am and 6am or night shift) within the past 6 mo
- Anticipated scheduled bariatric surgery within the next 3 months
- Chronic regular (\> 2 nights per week) of cannabis for sleep
- Diagnosis of uncontrolled psychiatric disease in the last six months , and/or history of schizophrenia or bipolar disorder. Controlled conditions will include major depressive disorder, panic disorder, generalized...
- Taking methylphenidate for ADHD. Unless on stable dose which will be reviewed by the PI to determine.
- Taking GLP-1 agonist semaglutide (Ozempic, Wegovy, Rybelsus), or tirzepatide (Mounjaro, Zepbound), or similar for weightloss, and planning to lose an additional 20lbs or more at the time of enrollment. (Screening...
- Presence of other critical comorbid conditions that would lead to inability to complete the study protocol (including follow-up for 2 years), or that would affect cognition (e.g. clinically relevant endocrine or...
- Does not have a regular sleeping environment (i.e., sleeps in a different setting \> 2 nights per week).
- Currently pregnant or planning to become pregnant.
- Prior diagnosis of a Central nervous system (CNS) disease, such as multiple sclerosis, stroke, Parkinson's disease, Alzheimer's disease, epilepsy, a loss of consciousness \> 24 hours, or traumatic brain injury as...
- Near-miss or prior automobile accident "due to sleepiness" within the past 12 months.
- Employed as a commercial driver during the study (for example, bus drivers, train engineers, airplane pilots).
- Any use of neuroleptics, benzodiazepines, barbiturates, opiates or anti-amyloid therapies.
- Use of other cognitive enhancing drugs will also be excluded if initiated in the last 3 months, or not on stable dose.
- Consumption of \>14 alcohol drinks per week, unless alcohol consumption can be reduced if initiated in the last 3 months
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
- New York, New York, United States
- Pittsburgh, Pennsylvania, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States; New York, New York, United States; Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.