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Belépés
Fut, nem toborozFázis nélkül

MCI: CPAP Treatment of OSA (Memories2)

A legfontosabb adatok

Ki végzi
University of Pennsylvania
Hol
Austin, Charlottesville, Philadelphia és St Louis (Egyesült Államok)Mind a 4 helyszín megnézése
Azonosító
Állapot
Fut, nem toboroz
Résztvevők
327 fő vett részt
Kezdés
2018. jan. 19.
Befejezés
2025. júl. 1.
A vizsgálat típusa
Beavatkozással járó, 3 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
A vizsgált kezelések
  • CPAP
A regiszteradat frissítve
2023. április 12.

Ki vehet részt

Életkor
55 év – 85 év
Nem
Nők és férfiak
Egészséges önkéntesek
Nem vehetnek részt

A regiszter feltételei, szó szerint

Mind a 21 feltétel megnézéseKevesebb

Ki vehet részt

  • age 55-85 years
  • moderate to severe OSA as defined by an AHI ≥ 15 events/hr, or no apnea defined by an AHI<5 events/hr using American Academy of Sleep Medicine (AASM) diagnostic methodology as determined on a diagnostic polysomnography
  • Scoring education adjusted scores 28-35 (inclusive) on optional Telephone Interview for Cognitive Status Modified (pre-screen)
  • Scoring 0-0.5 on the Clinical Dementia Rating Scale (CDR)
  • Scoring 23-30 on the Mini Mental State Examination (MMSE) (exceptions may be made for participants with <8 years of education as determined by the clinical research team)
  • Memory impairment approximately 1.0-1.5 standard deviations below normal (adjusted for age and education) determined by scores on the Logical Memory II a test from the Wechsler memory scale
  • permitted medications (antidepressants, etc.) stable for at least 4 weeks (12 weeks for cholinesterase inhibitors/memantine) as per ADNI3 criteria
  • Non-depressed: Scoring < 6 on the Geriatric Depression Scale
  • study partner, defined as an informant/caregiver who will be able to answer questions about the study participant, and meets one of the following criteria: (a) lives with the participant; (b) spends at least 3 times per week in-person contact with the participant; (c) spends at least 3 times per week in phone contact with the participant; or (d) spends at least 10 hours per week in any combination of phone or in person contact
  • adequate visual and auditory acuity to allow testing
  • Post-menopause or surgically sterile
  • testability - willing and able to complete baseline, 6-month, and 1-year outcome measures, and willing to send in the CPAP Smartcard for adherence
  • completed at least 6 grades of education; and
  • fluent in English or Spanish

Ki nem vehet részt

  • received and was adherent to CPAP or bi-level pressure for OSA within the past 6 months
  • any significant neurologic disease other than aMCI, such as Parkinson's Disease, Huntington's disease, normal pressure hydrocephalus, progressive supranuclear palsy, multiple sclerosis, head trauma followed by permanent neurologic deficits or known congenital brain structure abnormalities; within the past 6 months brain tumor, or seizure disorder, or subdural hematoma, or post-stroke (based on Modified Hachinski Ischemic Score)
  • Optional: MRI exclusions - presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin, or body; however, the participant has the option of participating in the study without having an MRI
  • psychiatric disorders, including uncontrolled major depression, newly diagnosed or exacerbation in past 6 months of bipolar disorder as described in the DSM-IV, psychotic features, agitation or behavioral problems within the past 6 months that could lead to difficulty complying with the protocol, or history of schizophrenia (DSM-IV criteria)
  • history of alcohol abuse or dependence within the past 6 months (DSM-IV criteria)
  • any current significant systemic illness or unstable medical condition that could lead to difficulty in complying with the protocol (such as unstable cardiovascular disease); current use of supplemental oxygen or hypoxemia indicated by documented daytime oxyhemoglobin saturation <90% on room air, uncontrolled thyroid disease (to be included must be on stable dose of thyroid medication for >6 months), uncontrolled cirrhosis, cancer diagnosis within the past 6 months (exceptions may be made at the PI's discretion depending on cancer severity and the treatment required), clinically significant laboratory abnormalities such as reported untreated folate, B12, or TSH disease, or resident of a skilled nursing facility
  • participation in clinical studies involving neuropsychological measures being conducted more than twice a year

Helyszínek itt: Egyesült Államok

  • University of Texas at AustinAustin, Egyesült Államok
  • University of VirginiaCharlottesville, Egyesült Államok
  • University of PennsylvaniaPhiladelphia, Egyesült Államok
  • Washington University in St. LouisSt Louis, Egyesült Államok

A vizsgálatról

Mit akar kideríteni a vizsgálat

The purpose of this project is to determine whether obstructive sleep apnea (OSA) treatment with positive airway pressure therapy (CPAP) can delay the progression of cognitive impairment in patients with amnestic Mild Cognitive Impairment (MCI) as measured by cognitive testing, and brain magnetic resonance imaging (MRI) scans. Study participants will be assessed at baseline, six-month (cognitive tests only) and one-year follow-up.

A vizsgálat 3 csoportja

  • CPAP adherentA vizsgált kezelés

    Study participants in this arm are using the CPAP intervention consistently

    Kezelés: CPAP

  • CPAP non-adherentMár használt kezelés, összehasonlításként

    Study participants in this arm are not using the CPAP intervention consistently

    Kezelés: CPAP

  • No OSANincs vizsgálati kezelés, összehasonlításként

    Study participants who do not have OSA

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
Changing the Trajectory of Mild Cognitive Impairment With CPAP Treatment of Obstructive Sleep Apnea
A regiszteradat frissítve
2023. április 12.