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NCT05988385Toboroz

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

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

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 26.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

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. Both groups will continue follow-up for 24 months on stable therapy to determine if sustained improvements in sleep are associated with improvement in cognitive function and AD biomarkers.

Állapot (regiszter)
Toboroz
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
200 (tervezett)
Első benyújtás
2023. máj. 22.
Kezdés
2024. aug. 29.
Elsődleges befejezés
2027. aug. 31.
Fő szponzor
California Pacific Medical Center Research Institute
Betegségek
Alzheimer-kór
NCT-szám
NCT05988385

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó
  • Tervezett résztvevők: 200
  • 2024. aug. 29. és az elsődleges befejezés (2027. aug. 31.) között
  • 4 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

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Korábbi kezelés

  • Anticipated scheduled bariatric surgery within the next 3 months
  • 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. PI Discretion for determination of why they are taking the drug based on conversation with subject and medical chart, will be documented in form of Note-to-file in the subject's records
  • 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 identified by the Cumulative Illness Rating Scale for Geriatrics (CIRS). Participants who are diagnosed with MCI or Alzheimer's disease based on neuropsychological testing will be excluded. Delirium in the last 12 months.
  • Near-miss or prior automobile accident "due to sleepiness" within the past 12 months.
  • 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.

Más betegség

  • Documented diagnosis of circadian rhythm disorder
  • Other sleep-related breathing disorders (central sleep apnea, etc) based on AASM criteria
  • 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 anxiety disorder, OCD, substance use disorders, and alcohol abuse/dependence. Personality disorders and neurodevelopmental disorders (e.g. autism, ADHD) are allowed if cognition is within normal limits.
  • Presence of other comorbid condition 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 hematological conditions).

Egyéb

  • Documented diagnosis of chronic insomnia, or sleep onset insomnia based on Insomnia Severity Index - an answer of severe or very severe in the screening form
  • Any current use of supplemental oxygen
  • Current shift work involving night shift (regular work between 12am and 6am or night shift) within the past 6 mo
  • Chronic regular (> 2 nights per week) of cannabis for sleep
  • Chronic regular use (> 2 nights per week) of sedatives/hypnotics for sleep
  • Taking methylphenidate for ADHD. Unless on stable dose which will be reviewed by the PI to determine.
  • 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.
  • Employed as a commercial driver during the study (for example, bus drivers, train engineers, airplane pilots).
  • Consumption of >14 alcohol drinks per week, unless alcohol consumption can be reduced if initiated in the last 3 months.

Kiket keres a vizsgálat

  • 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 testing - Testing must have been completed in past 12 months or confirmed by repeat test
  • 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

Életkor a regiszterben: 55 év – 85 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (4)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
Mount SinaiNew YorkEgyesült ÁllamokToboroz
New York UniversityNew YorkEgyesült ÁllamokToboroz
University of PittsburghPittsburghEgyesült ÁllamokToboroz
University of ArizonaTucsonEgyesült ÁllamokToboroz

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