Obstructive Sleep Apnea Clinical Trial
— ESSENTIALOfficial title:
The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults (ESSENTIAL) Study
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.
Status | Not yet recruiting |
Enrollment | 200 |
Est. completion date | June 2028 |
Est. primary completion date | June 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 55 Years to 75 Years |
Eligibility | Inclusion Criteria: - Cognitively normal (MoCA=24, Clinical Dementia Rating [CDR]=0) with a minimum of 12 years of education - Males and females, 55-75 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) - No OSA treatment - Able and willing to be treated for OSA - Fluency in English or Spanish Exclusion Criteria: - Any other sleep or breathing disorder requiring supplemental oxygen. This includes circadian rhythm abnormalities, including irregular sleep-wake cycles defined as self-reported '=3 sleep episodes per 24-hr period' or 'day to day irregularity of sleep/wake times greater than 2 hours' - Anticipated scheduled bariatric surgery - Chronic use of any sedative, stimulant, neuroleptic drugs, or other medications limiting validity of cognitive tests - The presence of critical comorbid conditions, including clinically relevant endocrine or hematological conditions, substance abuse, preexisting cognitive, psychiatric, or neurological conditions, and pregnancy. History of stroke or MRI evidence of vascular damage, history of transient ischemic attacks or extensive white matter lesions (Fazekas scale >2) will also be excluded. |
Country | Name | City | State |
---|---|---|---|
United States | Mount Sinai | New York | New York |
United States | New York University | New York | New York |
United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
United States | University of Arizona | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
California Pacific Medical Center Research Institute | Icahn School of Medicine at Mount Sinai, National Institute on Aging (NIA), New York University, University of Arizona, University of Pittsburgh |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Cognitive Impairment Severity | Severity of cognitive impairment based on normed cutoffs with the National Alzheimer's Coordinating Centers Uniform Data Set-3 (UDS-3) assessment. | Baseline | |
Other | Cognitive Impairment Severity | Severity of cognitive impairment based on normed cutoffs with the National Alzheimer's Coordinating Centers Uniform Data Set-3 (UDS-3) assessment. | 24 months | |
Other | Clinical Dementia Rating (CDR) Scale (0-3) | Clinical Dementia Rating on a scale of 0-3 based on clinical assessment, 0 being no impairment, and 3 being severe impairment. | Baseline | |
Other | Sleepiness Score | Epworth Sleepiness Scale (ESS) Questionnaire Score. Higher scores mean more severe sleepiness. | Baseline | |
Other | Sleepiness Score | Epworth Sleepiness Scale (ESS) Questionnaire Score. Higher scores mean more severe sleepiness. | 3 months | |
Other | Sleepiness Score | Epworth Sleepiness Scale (ESS) Questionnaire Score. Higher scores mean more severe sleepiness. | 24 months | |
Other | Insomnia Severity | Insomnia Severity Index (ISI) Questionnaire Score. Higher scores mean more severe insomnia symptoms. | Baseline | |
Other | Insomnia Severity | Insomnia Severity Index (ISI) Questionnaire Score. Higher scores mean more severe insomnia symptoms. | 3 months | |
Other | Insomnia Severity | Insomnia Severity Index (ISI) Questionnaire Score. Higher scores mean more severe insomnia symptoms. | 24 months | |
Other | Psychiatric Symptom Questionnaires: Geriatric Depression Scale (GDS) | Scores of 0-4 are considered normal, depending on age, education, and complaints; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression. | Baseline | |
Other | Psychiatric Symptom Questionnaires: Hamilton Anxiety Rating Scale (HAM-A) | Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. | Baseline | |
Other | Psychiatric Symptom Questionnaires: Clinician-Administered PTSD Scale (CAPS) | CAPS-5 symptom cluster severity scores are calculated by summing the individual item severity scores for symptoms corresponding to a given DSM-5 cluster: Criterion B (items 1-5); Criterion C (items 6-7); Criterion D (items 8-14); and, Criterion E (items 15-20). Severity scores range from 0-4, with 0 being absent to 4 being extreme/incapacitating. | Baseline | |
Primary | Change in overnight memory retention on the A-B verbal paired associates task | Mean change in percent correct memory | 3 months | |
Primary | Change in overnight memory retention on the A-B verbal paired associates task | Mean change in percent correct memory | 12 months | |
Primary | Change in overnight memory retention on the A-B verbal paired associates task | Mean change in percent correct memory | 24 months | |
Primary | Change in Aß42/ Aß40 ratio | Mean change in the Aß42/ Aß40 ratio in picograms per millimeter (pg/ml) | 3 months | |
Primary | Change in Aß42/ Aß40 ratio | Mean change in the Aß42/ Aß40 ratio in picograms per millimeter (pg/ml) | 24 months | |
Primary | Change in Plasma P-tau181 | Mean change in p-tau181 levels in the plasma in picograms per millimeter (pg/ml) | 3 months | |
Primary | Change in Plasma P-tau181 | Mean change in p-tau181 levels in the plasma in picograms per millimeter (pg/ml) | 24 months | |
Primary | Change in P-tau217 | Mean change in p-tau217 levels in the plasma in picograms per millimeter (pg/ml) | 3 months | |
Primary | Change in P-tau217 | Mean change in p-tau217 levels in the plasma in picograms per millimeter (pg/ml) | 24 months | |
Primary | Change in Neurofibrilary light (NfL) | Mean change in NfL levels in the plasma in picograms per millimeter (pg/ml) | 3 months | |
Primary | Change in Neurofibrilary light (NfL) | Mean change in NfL levels in the plasma in picograms per millimeter (pg/ml) | 24 months | |
Primary | Preclinical Cognitive Composite Score | Mean change in Preclinical Cognitive Composite Score. | 3 months | |
Primary | Preclinical Cognitive Composite Score | Mean change in Preclinical Cognitive Composite Score. | 12 months | |
Primary | Preclinical Cognitive Composite Score | Mean change in Preclinical Cognitive Composite Score. | 24 months | |
Secondary | Change in Task-switching Accuracy | Change in Task-switching Mean Percent Accuracy | 3 months | |
Secondary | Change in Task-switching Accuracy | Change in Task-switching Mean Percent Accuracy | 12 months | |
Secondary | Change in Task-switching Accuracy | Change in Task-switching Mean Percent Accuracy | 24 months | |
Secondary | Change in Task-switching Reaction Time | Change in Task-switching Mean Reaction Time in milliseconds | 3 months | |
Secondary | Change in Task-switching Reaction Time | Change in Task-switching Mean Reaction Time in milliseconds | 12 months | |
Secondary | Change in Task-switching Reaction Time | Change in Task-switching Mean Reaction Time in milliseconds | 24 months | |
Secondary | Change in Psychomotor Vigilance Task (PVT) lapses | Mean change in number of lapses | 3 months | |
Secondary | Change in Psychomotor Vigilance Task (PVT) lapses | Mean change in number of lapses | 12 months | |
Secondary | Change in Psychomotor Vigilance Task (PVT) lapses | Mean change in number of lapses | 24 months | |
Secondary | Change in Psychomotor Vigilance Task (PVT) reaction time | Mean change in median reaction time in milliseconds. | 3 months | |
Secondary | Change in Psychomotor Vigilance Task (PVT) reaction time | Mean change in median reaction time in milliseconds. | 12 months | |
Secondary | Change in Psychomotor Vigilance Task (PVT) reaction time | Mean change in median reaction time in milliseconds. | 24 months |
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