The Relationship Between Obstructive Sleep Apnea and Alzheimer's Disease: Evidence and Effectiveness
NCT ID: NCT05433883
Last Updated: 2022-06-27
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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UNKNOWN
NA
60 participants
INTERVENTIONAL
2020-11-03
2022-10-31
Brief Summary
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Detailed Description
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The research plan to enroll 15 simple snoring patients (apnea/hypopnea \<5, control group), 30 severe OSA patients (apnea/hypopnea \>30, treatment group), and 15 mild cognitive impairment patients (comparative group). All patients complete Mini-Mental State Examination, peripheral blood sample for plasma Aβ42, Aβ40, Aβ42/Aβ40, Tau, NfL; amyloid deposit in18F-florbetapir PET; and Taiwan smell identification test. Thirty severe OSA patients (AHI\>30, treatment group) receive comprehensive upper airway surgery with/without bariatric surgery and repeat postoperative assessment in polysomnography and aforementioned examinations 1 year later.
The data from the study can be used to explore the association between polysomnography and AD-related examinations, to compare the perioperative changes in polysomnography and AD-related examinations, to correlate the perioperative changes between polysomnography and AD-related examinations. The contributions of the study are to clarify the hypothesis: severe OSA is early stage and one of the etiology contributing to the development of AD, and sleep surgery improves OSA and consequently modify the process of AD, early detection of cognition and olfactory function in OSA patients can contribute to diagnosis of early stage AD and consequently early treatment to modify the development of AD.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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treatment group
30 severe OSA patients (apnea/hypopnea \>30)
sleep surgery
Thirty severe OSA patients (AHI\>30, treatment group) receive comprehensive upper airway surgery with/without bariatric surgery and repeat postoperative assessment in polysomnography and aforementioned examinations 1 year later.
control group
15 simple snoring patients (apnea/hypopnea \<5 )
No interventions assigned to this group
comparative group
15 mild cognitive impairment patients.
No interventions assigned to this group
Interventions
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sleep surgery
Thirty severe OSA patients (AHI\>30, treatment group) receive comprehensive upper airway surgery with/without bariatric surgery and repeat postoperative assessment in polysomnography and aforementioned examinations 1 year later.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. control group, AHI\<5 (n=15)
3. treatment group, AHI\>30 (n=30)
4. Comparative group, mild cognitive impairment (n=15)
50 Years
ALL
Yes
Sponsors
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Chang Gung Memorial Hospital
OTHER
Responsible Party
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Principal Investigators
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professor
Role: STUDY_CHAIR
Chang Gung Memorial Hospital
Locations
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Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
Countries
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Other Identifiers
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Hsueh-Yu Li
Identifier Type: -
Identifier Source: org_study_id
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