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MCI: CPAP Treatment of OSA (Memories2) (MCI:OSA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03113461
Recruitment Status : Recruiting
First Posted : April 13, 2017
Last Update Posted : July 29, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Sleep Apnea, Obstructive Device: CPAP Not Applicable

Detailed Description:

A growing number of research studies suggest that obstructive sleep apnea (OSA), characterized by episodic nocturnal collapse of the upper airway and reduction/cessation of breathing leading to significant nocturnal hypoxia, is associated with an increased risk of cognitive impairment. OSA is effectively treated with continuous positive airway pressure (CPAP), a pressurized nasal/face mask worn during sleep, but health care providers do not often prescribe it for Mild Cognitive Impairment (MCI) because there are no large, prospective research studies in this population confirming efficacy.

This multi-site study will have a sample size of n=460 divided into three groups followed for one year: 1) a CPAP adherent group (approximately n=200); 2) two control groups consisting of 2a) a CPAP non-adherent control group (approximately n=160) and 2b) a no apnea control group (n=100). This will allow us to confirm whether CPAP treatment, controlling for risk factors such as neuroimaging findings and OSA severity at baseline, predicts the primary outcome of cognitive function at 1-year follow-up. Study participants will also undergo an Amyloid PET scan, use wearable activity monitors and functional/structural MRI brain scans.

This research study will thus examine the one year effects of CPAP on cognitive function and elucidate physiological mechanisms for cognitive decline in aMCI and OSA.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 460 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: CPAP intervention
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Changing the Trajectory of Mild Cognitive Impairment With CPAP Treatment of Obstructive Sleep Apnea
Actual Study Start Date : October 15, 2017
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : July 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: CPAP adherent
Study participants in this arm are using the CPAP intervention consistently
Device: CPAP
non-invasive positive airway pressure applied using an oronasal mask
Other Name: continuous positive airway pressure therapy

Active Comparator: CPAP non-adherent
Study participants in this arm are not using the CPAP intervention consistently
Device: CPAP
non-invasive positive airway pressure applied using an oronasal mask
Other Name: continuous positive airway pressure therapy

No Intervention: No OSA
Study participants who do not have OSA



Primary Outcome Measures :
  1. Digit Symbol-Coding test [ Time Frame: one-year follow-up ]
    incorporates both elements of memory and processing speed and correlates with executive functioning


Secondary Outcome Measures :
  1. Clinical Dementia Rating Scale [ Time Frame: one-year follow-up ]
    Assessment of global cognition



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. age 55-85 years;
  2. 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;
  3. Scoring education adjusted scores 28-35 (inclusive) on optional Telephone Interview for Cognitive Status Modified (pre-screen);
  4. Scoring 0-0.5 on the Clinical Dementia Rating Scale (CDR);
  5. Scoring 24-30 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);
  6. 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;
  7. permitted medications (antidepressants, etc.) stable for at least 4 weeks (12 weeks for cholinesterase inhibitors/memantine) as per ADNI3 criteria;
  8. Non-depressed: Scoring < 6 on the Geriatric Depression Scale;
  9. 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;
  10. adequate visual and auditory acuity to allow testing;
  11. Post-menopause or surgically sterile;
  12. testability - willing and able to complete baseline, 6-month, and 1-year outcome measures, and willing to send in the CPAP Smartcard for adherence;
  13. completed at least 6 grades of education; and
  14. fluent in English or Spanish.

Exclusion Criteria:

  1. 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);
  2. 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;
  3. 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);
  4. history of alcohol abuse or dependence within the past 6 months (DSM-IV criteria);
  5. 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, clinically significant laboratory abnormalities such as reported untreated folate, B12, or TSH disease, or resident of a skilled nursing facility;
  6. participation in clinical studies involving neuropsychological measures being conducted more than twice a year;
  7. received and was adherent to CPAP or bi-level pressure for OSA within the past 6 months;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03113461


Contacts
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Contact: Jennifer Morris, MS (215)-573-7293 jennifer.morris3@uphs.upenn.edu

Locations
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United States, Missouri
Washington University in St. Louis Recruiting
Saint Louis, Missouri, United States, 63130-4862
Contact: Brandye Mazdra    314-566-7038    bmazdra@wustl.edu   
Principal Investigator: Luqi Chi, MD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Grace Nathanson    215-746-7465    nathansa@pennmedicine.upenn.edu   
Principal Investigator: Nalaka Gooneratne, MD         
United States, Texas
University of Texas at Austin Recruiting
Austin, Texas, United States, 78701
Contact: Jamie L Fuentecilla, PhD    512-471-9462    jamie.fuentecilla@utexas.edu   
Contact: Eddy Vass    512-471-9462    eddy.vass@nursing.utexas.edu   
Principal Investigator: Kathy Richards, PhD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Colleen Webber       cmn6x@hscmail.mcc.virginia.edu   
Principal Investigator: Eric Davis, MD, PhD         
Sub-Investigator: Mark Quigg, MD         
Sub-Investigator: Matt Barrett, MD         
Sponsors and Collaborators
University of Pennsylvania
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Nalaka Gooneratne, MD, MSc Associate Professor
Principal Investigator: Kathy Richards, PhD Professor
Principal Investigator: David Wolk, MD Associate Professor

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03113461     History of Changes
Other Study ID Numbers: PD10057866
R01AG054435 ( U.S. NIH Grant/Contract )
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: July 29, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Pending

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by University of Pennsylvania:
cognitive impairment
sleep apnea
positive airway pressure therapy
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Cognitive Dysfunction
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Dyssomnias
Nervous System Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders