MCI: CPAP Treatment of OSA (Memories2)

NCT03113461 | Active Not Recruiting DMC FDA Device

• 2 other identifiers: PD10057866R01AG054435
• Study Type: interventional
• Target: 327
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Mild Cognitive Impairment; Sleep Apnea, Obstructive

Keywords

cognitive impairment; sleep apnea; positive airway pressure therapy

Outcome Measures

Primary Outcomes (1)

• Digit Symbol-Coding test

  incorporates both elements of memory and processing speed and correlates with executive functioning

  one-year follow-up

Secondary Outcomes (1)

• Clinical Dementia Rating Scale

  one-year follow-up

Study Arms (3)

CPAP adherent

EXPERIMENTAL

Study participants in this arm are using the CPAP intervention consistently

Device: CPAP

CPAP non-adherent

ACTIVE COMPARATOR

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

Device: CPAP

No OSA

NO INTERVENTION

Study participants who do not have OSA

Interventions

CPAP DEVICE

non-invasive positive airway pressure applied using an oronasal mask

Also known as: continuous positive airway pressure therapy

CPAP adherent; CPAP non-adherent

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• 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;
• received and was adherent to CPAP or bi-level pressure for OSA within the past 6 months;

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute on Aging (NIA): collaborator

Study Sites (4)

Washington University in St. Louis

St Louis, Missouri, 63130-4862, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Texas at Austin

Austin, Texas, 78701, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Nalaka Gooneratne, MD, MSc

  Associate Professor

  PRINCIPAL INVESTIGATOR

• Kathy Richards, PhD

  Professor

  PRINCIPAL INVESTIGATOR

• David Wolk, MD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: CPAP intervention

Study Record Dates

• First Submitted: April 9, 2017
• First Posted: April 13, 2017
• Study Start: January 19, 2018
• Primary Completion: January 31, 2023
• Study Completion: July 1, 2025
• Last Updated: April 12, 2023

Record last verified: 2023-04

Locations

US (4)