Is Obstructive Sleep Apnea Important in the Development of Alzheimer's Disease?
NCT ID: NCT05094271
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
260 participants
INTERVENTIONAL
2021-06-30
2025-05-20
Brief Summary
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Detailed Description
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Hypothesis 1: A substantial proportion of high AD risk patients with OSA should be O2 responsive as predicted using pathophysiological assessments.
Aim 2: We will perform an overnight mechanistic study of oxygen therapy vs. room air in high AD risk patients with OSA (recruited from Aim 1 and others if necessary). Given the frequent intolerance of PAP in elderly patients, we anticipate that oxygen therapy may be a viable therapeutic approach in this fragile population. We will focus on respiratory outcomes (primary outcome: apnea hypopnea index) but also assess sleep dependent memory consolidation on word pairs task given the major impact in the elderly.
Hypothesis 2: O2, compared to room air, will improve OSA and neurocognitive outcomes in select elderly OSA patients at risk of AD.
Aim 3: Preclinical AD with OSA and non-OSA controls, from Aim 1 will have structural and molecular brain imaging focusing on hippocampal atrophy as a predictor of memory consolidation. We will also assess amyloid and tau in the medial temporal region as function of OSA severity and as a predictor of neurocognitive function. This aim will lay the groundwork for designing a robust clinical trial using neuroimaging outcomes.
Hypothesis 3: Impairment in memory consolidation is a function of hippocampal size in OSA patients at risk of AD.
Aim 4: We will perform a pilot randomized trial of oxygen vs. PAP therapy in OSA patients with preclinical AD.
Hypothesis 4: In preclinical AD with OSA, oxygen will be a viable therapeutic strategy to improve memory.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Supplemental Oxygen during PSG
Subjects will be instrumented with a nasal cannula to receive 2L/min supplemental oxygen. The oxygen will be kept at a fixed rate, however, the participant will be titrated to receive a max of 4 liters per min to maintain sats \>90% based on oximetry readings.
Supplemental Oxygen
Subjects will be instrumented with a nasal cannula to receive 2L/min supplemental oxygen. The oxygen will be kept at a fixed rate, however, the participant will be titrated to receive a max of 4 liters per min to maintain sats \>90% based on oximetry readings.
Room Air during PSG
Subjects will be instrumented with a nasal cannula to receive 2L/min of pressurized room air. The room air will be kept at a fixed rate, however, the participant will be titrated to receive a max of 4 liters per min to maintain sats \>90% based on oximetry readings.
Room Air
Subjects will be instrumented with a nasal cannula to receive 2L/min pressurized room air. The room air will be kept at a fixed rate, however, the participant will be titrated to receive a max of 4 liters per min to maintain sats \>90% based on oximetry readings.
Supplemental Oxygen for 3 Months
Over a 12-week period, participants randomized to receive supplemental Oxygen for treatment of OSA will be contacted weekly to be asked about their adherence. Participants' adherence will also be monitored remotely through cloud-based monitoring.
Supplemental Oxygen
Subjects will be instrumented with a nasal cannula to receive 2L/min supplemental oxygen. The oxygen will be kept at a fixed rate, however, the participant will be titrated to receive a max of 4 liters per min to maintain sats \>90% based on oximetry readings.
PAP Therapy for 3 Months
Over a 12-week period, participants randomized to receive supplemental PAP therapy for treatment of OSA will be contacted weekly to be asked about their adherence. Participants' adherence will also be monitored remotely through cloud-based monitoring.
Continuous Positive Airway Pressure Machine
Continuous positive airway pressure is a form of positive airway pressure ventilation in which a constant level of pressure greater than atmospheric pressure is continuously applied to the upper respiratory tract of a person.
Interventions
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Supplemental Oxygen
Subjects will be instrumented with a nasal cannula to receive 2L/min supplemental oxygen. The oxygen will be kept at a fixed rate, however, the participant will be titrated to receive a max of 4 liters per min to maintain sats \>90% based on oximetry readings.
Continuous Positive Airway Pressure Machine
Continuous positive airway pressure is a form of positive airway pressure ventilation in which a constant level of pressure greater than atmospheric pressure is continuously applied to the upper respiratory tract of a person.
Room Air
Subjects will be instrumented with a nasal cannula to receive 2L/min pressurized room air. The room air will be kept at a fixed rate, however, the participant will be titrated to receive a max of 4 liters per min to maintain sats \>90% based on oximetry readings.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Gender: Men or Women
3. MOCA \> 26
4. Independently living and able to drive
5. OSA (AHI ≥ 15/h) or no OSA
6. Subjects must consent to waiving their right to obtain their PHS score (since the score is not yet actionable and could lead to social stress and ethical dilemmas)
Exclusion Criteria
2. History of COPD or asthma
3. Heart Failure Class III or IV, unstable cardiovascular disease, or uncontrolled hypertension
4. Neuromuscular Disease
5. Drowsy Driving (ESS \> 18/24)
6. Inability to complete study procedures, such as questionnaire that are only available/validated in English
7. Lack of decisional capacity to provide informed consent
8. Participants in whom magnetic resonance imaging Magnetic Resonance Imaging \[MRI\] is contraindicated including, but not limited to, those with a pacemaker, presence of metallic fragments near the eyes or spinal cord, or cochlear implant
9. Presence of a brain tumor or lobar stroke
10. Current drug or alcohol abuse/dependence
11. Prisoners
65 Years
85 Years
ALL
No
Sponsors
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University of California, San Diego
OTHER
Responsible Party
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Atul Malhotra
Professor, Medicine
Locations
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UCSD Sleep Research
La Jolla, California, United States
Countries
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Central Contacts
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Facility Contacts
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Pam DeYoung, RPSGT
Role: primary
Pamela DeYoung, RPSGT
Role: backup
References
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Holloway BM, Harding CD, DeYoung P, Kwan CG, Avetisyan L, Lui KK, Ancoli-Israel S, Banks SJ, Djonlagic I, Malhotra A. Comorbid insomnia and sleep apnea (COMISA) is associated with worse verbal episodic memory in older women. J Clin Sleep Med. 2025 Sep 30. doi: 10.5664/jcsm.11902. Online ahead of print.
Harding CD, Holloway BM, DeYoung PN, Kwan C, Djonlagic I, Ancoli-Israel S, Banks SJ, Malhotra A. Subjective daytime sleepiness, not sleep quality or hypoxia, predicts sleep-dependent memory consolidation in a cohort of older adults. J Clin Sleep Med. 2025 Jul 1;21(7):1217-1226. doi: 10.5664/jcsm.11648.
Other Identifiers
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200228
Identifier Type: -
Identifier Source: org_study_id