Investigating the link between obstructive sleep apnea and Alzheimer's disease
Is Obstructive Sleep Apnea Important in the Development of Alzheimer's Disease?
This study is testing if treating obstructive sleep apnea with oxygen therapy can help improve memory and thinking skills in older adults at risk for Alzheimer's disease.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 260 (estimated) |
| Ages | 65 Years to 85 Years |
| Sex | All |
| Sponsor | University of California, San Diego Academic / other |
| Locations | 1 site (La Jolla, California) |
| Trial ID | NCT05094271 on ClinicalTrials.gov |
What this trial studies
This study aims to explore how obstructive sleep apnea (OSA) may contribute to the progression of Alzheimer's disease (AD) in elderly individuals. It will assess the underlying mechanisms of OSA in high-risk AD patients using simplified techniques, and evaluate the effectiveness of oxygen therapy compared to room air on respiratory and cognitive outcomes. The study will also involve structural and molecular brain imaging to examine hippocampal atrophy as a predictor of memory consolidation. Participants will be closely monitored to determine the impact of OSA treatment on their cognitive health.
Who should consider this trial
Good fit: Ideal candidates are elderly individuals aged 65-85 years, both men and women, who have a diagnosis of obstructive sleep apnea or are matched controls without OSA.
Not a fit: Patients with severe cardiovascular issues, respiratory diseases, or those unable to complete study procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for elderly patients with obstructive sleep apnea at risk of developing Alzheimer's disease.
How similar studies have performed: While the relationship between sleep apnea and cognitive decline has been explored, this specific approach using oxygen therapy in high-risk AD patients is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 65-85 years 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: 1. Currently smoking 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
Where this trial is running
La Jolla, California
- UCSD Sleep Research — La Jolla, California, United States (Recruiting)
Study contacts
- Study coordinator: Pam DeYoung
- Email: sleepresearch@health.ucsd.edu
- Phone: 8582462154
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.