Is Obstructive Sleep Apnea Important in the Development of Alzheimer's Disease?

Browse trials for

• Sleep Apnea Syndromes 2,162
• Sleep Apnea, Obstructive 2,198
• Alzheimer Disease 3,678
• Sleep Wake Disorders 788

Keywords

• sleep
• OSA
• Sleep Apnea
• Obstructive Sleep Apnea
• Alzheimer Disease
• Sleep Disorder
• Alzheimer

Sleep Apnea Syndromes

2,162 studies on the registry are indexed under Sleep Apnea Syndromes; 290 are open to participants now.

This study's enrollment of 182 is above the median of 53 across 1,386 interventional studies indexed under Sleep Apnea Syndromes.

Lead sponsor

University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.

Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.

Study arms

• Active comparator
  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.

  Other: Supplemental Oxygen

• Placebo comparator
  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.

  Other: Room Air

• Experimental
  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.

  Other: Supplemental Oxygen

• Experimental
  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.

  Device: Continuous Positive Airway Pressure Machine

Interventions

• OtherSupplemental 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.

  Also known as: Oxygen, O2

• DeviceContinuous 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.

  Also known as: CPAP, PAP

• OtherRoom 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.

  Also known as: Placebo

Primary outcomes

1. Apnea Hypopnea Index - Crossover

   The number of times a person stops breathing and periods of shallow breathing with a marked decrease in blood oxygen concentration every hour on average. A score lower than five indicates normal sleep (no sleep apnea), 5-15 indicates mild sleep apnea, 15-30 indicates moderate sleep apnea, and a score greater than 30 indicates severe sleep apnea. Result specified as change from room air condition to oxygen condition during the crossover trial

   Time frame: Over 8 hours on each of the two crossover treatment nights

2. Loop Gain (LG) - Crossover

   A method used to measure respiratory stability of the negative feedback chemoreflex control system using a specialized Positive Airway Pressure machine called a pCrit. The overall loop gain of the ventilatory system reflects the ratio of the ventilatory response to the disturbance that elicited the response (LG = ventilatory response/ventilatory disturbance). The higher the loop gain, the potentially more unstable the respiratory control system becomes. Result specified as change from room air condition to oxygen condition during the crossover trial

   Time frame: Over 8 hours on each of the two crossover treatment nights

3. Neuroimaging - BRAAK12 tauPET

   MRI and PET Scans. This study will examine pre-clinical Alzheimer's disease with OSA patients using brain imaging (structural MRI and amyloid/tau PET). MRI will be conducted to provide a structural image suitable for coregistering the PET image and observing white matter integrity. The scan should take 35 minutes. These will be MPRAGE images collected using the standard ADNI protocol at the in-house 3T MRI scanner at the University of California San Diego Altman Clinical and Translational Research Institute (ACTRI). The PET scan should take 70-90 minutes and uses the 18F-MK6240 tracer. Result given is the Standardized Uptake Value Ratio (SUVR) of tau protein in the BRAAK1-2 regions, the earliest regions to develop tau pathology in Alzheimer's disease

   Time frame: Two 1-hour long scans

Secondary outcomes

1. Epworth Sleepiness Scale (ESS) - Parallel

   A self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life. Result specified as change from week 1 to week 12 during the parallel treatment trial

   Time frame: 12 weeks

2. Pittsburgh Sleep Quality Index (PSQI) - Parallel

   A 19-item, self-rated questionnaire designed to measure sleep quality and disturbance over the past month. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality. Result specified as change from week 1 to week 12 during the parallel treatment trial

   Time frame: 12 weeks

3. Insomnia Severity Index (ISI) - Parallel

   A 7-item self-report form to assess insomnia severity. Total score categories: 0-7 = No clinically significant insomnia, 8-14 = Subthreshold insomnia, 15-21 = Clinical insomnia (moderate severity), 22-28 = Clinical insomnia (severe). Result specified as change from week 1 to week 12 during the parallel treatment trial

   Time frame: 12 weeks

Baseline characteristics

Publications

• 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. PubMed 40135690 ↗
• 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 is associated with worse verbal episodic memory in older females. J Clin Sleep Med. 2025 Dec 1;21(12):2129-2138. doi: 10.5664/jcsm.11902. PubMed 41025403 ↗

Study documents

• Protocol and statistical analysis plan · Apr 24, 2025
• Informed consent form · Mar 4, 2024

Documents are hosted by the registry — open the source record to download them.