The Relationship Between Obstructive Sleep Apnea and Alzheimer's Disease: Evidence and Effectiveness (OSA)

June 22, 2022 updated by: Chang Gung Memorial Hospital
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Obstructive sleep apnea and Alzheimer's disease are both highly prevalent and age-related chronic disease with significant impacts on global public health. The link between OSA and AD showed an inter-dependent relationship. Our genetic study showed the expressions of AD-associated genes (CCL2, IL6, CXCL8, HLA-A, IL1RN) in severe OSA patients. Our epidemiological study revealed OSA patients were significantly associated with a higher incidence of AD (adjusted hazard ratio: 2.12) in comparison to non-OSA subjects and treated OSA patients exhibited a significantly reduced risk of AD (incidence rate ratio: 0.23) compared with non-treated OSA patients. Possible mechanisms of OSA in contributing to AD are sleep fragmentation, intermittent hypoxia, intrathoracic swings, and olfactory dysfunction. The cognitive decline in AD seems progressive and irreversible, by contrast, OSA sharing similar cognitive impairment is treatable. The purposes of this study are (1) to explore the relationship and mechanism between OSA and AD, and establish an alarm system as early stage of AD in OSA patients, (2) to testify the improvement of OSA can feedback to ameliorate cognitive impairment and modify the process of AD.

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taoyuan, Taiwan, 333
        • Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. age >50 years
  2. control group, AHI<5 (n=15)
  3. treatment group, AHI>30 (n=30)
  4. Comparative group, mild cognitive impairment (n=15)

Exclusion Criteria:

The exclusion criteria were definite neurologic disorders affecting brain structure (e.g., stroke, traumatic head injury or epilepsy), unstable medical diseases involving the heart, lungs, liver or kidneys, chronic insomnia, allergic rhinitis/paranasal sinusitis and alcohol or substance abuse/dependence currently or in the past one year.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: treatment group
30 severe OSA patients (apnea/hypopnea >30)
Procedure: 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 Names:
  • comprehensive upper airway surgery
No Intervention: control group
15 simple snoring patients (apnea/hypopnea <5 )
No Intervention: comparative group
15 mild cognitive impairment patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
polysomnography
Time Frame: one year
simple snoring patients (apnea/hypopnea <5),severe OSA patients (apnea/hypopnea >30)
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mini-Mental State Examination
Time Frame: one year
Cognitive assessment in the present study is Mini Mental Status Examination (MMSE). The MMSE is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment.
one year
peripheral blood sample for plasma Aβ42, Aβ40, Aβ42/Aβ40, Tau, NfL
Time Frame: one year
Every subject provided a 20-ml venous blood sample (K3 EDTA, lavender-top tube). Samples were collected under non-fasting conditions between 9 AM and 2 PM. The blood samples were centrifuged at 3,000 × g for 20 minutes within half an hour of collection, and then plasma was aliquoted into cryotubes (1 ml per tube) and stored at -80 °C.
one year
amyloid deposit (18F-florbetapir PET)
Time Frame: one year
The radiosynthesis of 18F-florbetapir (AV-45) and amyloid PET data acquisition followed the same procedures as previously described . A fixed dose approximate of 10mCi (370 MBq) 18F-florbetapir (AV-45) will be given to each subject. 10-minute image will be acquired 50-60min post injection using a Biograph mMR PET/MR System or PET/CT scanner.
one year
Taiwan smell identification test
Time Frame: one year
The TWSIT questionnaire consisted of two questionnaires (test 1 and test 2), which contained the same multi-choice questions but in different sequence. Eight odorants (honey, peach, passion fruit, cantaloupe, lemon, smoked plum, garlic, coffee, jasmine), which are familiar to Taiwanese with a high identification rate (more than 95%), were identified and used in the questionnaires.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Study Chair: professor, Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2020

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

June 22, 2022

First Submitted That Met QC Criteria

June 22, 2022

First Posted (Actual)

June 27, 2022

Study Record Updates

Last Update Posted (Actual)

June 27, 2022

Last Update Submitted That Met QC Criteria

June 22, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hsueh-Yu Li

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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