Clinical Trials Logo

Clinical Trial Summary

Obstructive sleep apnea (OSA) is recurrent episodes of partial or complete obstruction of the upper airway during sleep that causes intermittent hypoxia and sleep fragmentation and potentially lead to cardiometabolic and neurocognitive sequelae. Chronic intermittent hypoxia, sleep fragmentation of OSA, and insufficient sleep have been significantly associated with higher risks of neurocognitive impairment, including mild cognitive impairment (MCI) and Alzheimer's disease. Thus, sleep and sleep apnea might be modifiable factors to neurocognitive impairment. Positive airway pressure (PAP) is the first line of treatment to maintain open airways for patients with OSA. Improving sleep, sleep apnea and circadian function could be a high-value intervention target to alleviate cognitive impairment and decline in subjects with mild neurocognitive impairment. Amyloid accumulation in brain tissue is a distinct feature of Alzheimers' disease, which is associated with potential impairment of neurocognition clinically. It predicts memory decline in initially cognitively unimpaired individuals. The study explores the associations between sleep apnea, cognitive function and cerebral imaging and the role of PAP therapy on neurocognitive trajectory in these patients with subjective cognitive impairment /mild cognitive impairment (SCI/MCI).


Clinical Trial Description

Obstructive sleep apnea (OSA) is recurrent episodes of partial or complete obstruction of the upper airway during sleep . Chronic intermittent hypoxia, sleep fragmentation of OSA, and insufficient sleep have been significantly associated with higher risks of neurocognitive impairment, including mild MCI and Alzheimer's disease. Thus, sleep and sleep apnea might be modifiable factors contributing towards neurocognitive impairment . Improving sleep and sleep apnea could be a high-value intervention to alleviate cognitive impairment and decline in subjects with mild neurocognitive impairment. Amyloid accumulation in brain tissue is a distinct feature of Alzheimer's disease, which is associated with potential impairment of neurocognition clinically. It predicts memory decline in initially cognitively unimpaired individuals. Research suggested that cerebrospinal fluid amyloid-β42 levels showed significant differences in subjects with moderate/severe OSA compared with healthy control. Investigators hypothesize that (i) OSA is a determinant of neurocognitive decline, and regular PAP therapy for OSA could reduce this decline in subjects presenting with subjective cognitive impairment (SCI) or MCI; (ii) OSA may contribute to cerebral amyloid burden in these subjects with clinical diagnosis of SCI/MCI. This study (i) assesses the role of obstructive sleep apnea as a potential determinant of neurocognitive status and the impact of OSA therapy (CPAP or other interventions) on neurocognitive decline (ii) evaluates if OSA increases cerebral amyloid deposition using PET imaging. Subjects are recruited from Memory clinic and who have undergone a study with sleep questionnaires, neurocognitive tests and home sleep apnea test (HSAT). Subjects with OSA (identified on HSAT) will be referred for management of OSA per usual clinical criteria. Sleep questionnaires and cognitive assessment tests will be reassessed at six months and one year, and determinants to neurocognitive changes will be analyzed. Amyloid PET-MRI brain will also be done at baseline. Owing to resource constraints, investigators can only provide PET-MRI investigation for 90 subjects ( 60 subjects with moderate/severe OSA to be compared with 30 subjects with no OSA) . ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06150352
Study type Observational
Source The University of Hong Kong
Contact Sau Man Mary Ip, MD
Phone 2255 4605
Email msmip@hku.hk
Status Recruiting
Phase
Start date September 26, 2023
Completion date March 31, 2027

See also
  Status Clinical Trial Phase
Recruiting NCT05857384 - Bioavailability, Bioequivalence and Tolerability of IHL-42X Compared to the Reference Drugs Phase 1
Recruiting NCT04547543 - Follow-up of Apneic Patients by Visio-consultation N/A
Recruiting NCT05371509 - Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study N/A
Completed NCT02515357 - Mediterranean Diet/Lifestyle Intervention in Obstructive Sleep Apnea N/A
Completed NCT05582070 - Effect on Sleep of Surgical Treatment of Severe Nasal Obstruction N/A
Active, not recruiting NCT03189173 - Combined Upper-airway and Breathing Control Therapies for Obstructive Sleep Apnea Phase 2
Completed NCT04084899 - The Effect of CPAP on Lung Hyperinflation in Patients With OSA
Completed NCT03032029 - Registry on the Treatment of Central and Complex Sleep-Disordered Breathing With Adaptive Servo-Ventilation
Recruiting NCT04028011 - Clinical Evaluation of a Wearable Technology for the Diagnosis of Sleep Apnoea
Recruiting NCT06047353 - Community Health Advocates for Motivating PAP Use in Our Neighborhoods. N/A
Completed NCT05253963 - Acute Effect of CPAP on Weight in Patients With Obstructive Sleep Apnea N/A
Recruiting NCT06029959 - Stroke and CPAP Outcome Study 3 N/A
Completed NCT03589417 - Postural Stability, Balance and Fall Risk in Patients With Obstructive Sleep Apnea
Recruiting NCT04335994 - ENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing N/A
Withdrawn NCT04063436 - Evaluation of a New Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea N/A
Recruiting NCT05385302 - Sociological Determinants of Positive Airway Pressure Adherence in OSA Patients
Recruiting NCT04572269 - Metabolomics of Obstructive Sleep Apnea
Not yet recruiting NCT06467682 - 12-week Tele-exercise Program in Patients With OSA N/A
Withdrawn NCT04011358 - Retinal Vein Occlusion and Obstructive Sleep Apnea: A Case Control Study N/A
Completed NCT03060915 - Actigraphy Sleep Parameters in Obstructive Sleep Apnea Patient's N/A