Obstructive Sleep Apnea, Obstructive Sleep Apnea (OSA), OSA
Conditions
Keywords
obstructive sleep apnea, OSA
Brief summary
The purpose of this research is to investigate whether enhancing systemic lymphatic drainage improves glymphatic function in patients with obstructive sleep apnea (OSA).
Detailed description
This proof-of-concept, pre-post open-label clinical trial will enroll 12 adult patients aged 50 and older with previously treated OSA (≥6 months of CPAP adherence). Participants will undergo biomarker testing and sleep architecture analysis using ambulatory home sleep trackers (Somfit) before and after one month of nightly AMLDT intervention. The significance of this study lies in its potential to uncover a novel, non-invasive therapeutic approach to enhance glymphatic clearance during sleep in OSA patients. The anticipated findings may inform future strategies for mitigating the risk of neurodegenerative diseases through targeted manipulation of the lymphatic system.
Interventions
DEVICEAutomated manual lymphatic drainage therapy (AMLDT) device
The AMLDT device (Neuroglide) is an FDA-cleared Class II medical device (K202693) for over-the-counter use for pain. It mimics manual lymphatic drainage through a pneumatic mat that performs rhythmic inflation and deflation in ascending fashion.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 50 years and older * Diagnosed with obstructive sleep apnea * On stable, effective, and compliant CPAP therapy for a minimum of 6 months * Willing and able to provide informed consent * Willing and able to use automated manual lymphatic drainage device (Neuroglide) nightly for 1-month and participate in at-home sleep monitoring * Stable on a medication regimen for comorbid medical or mental health disorders for at least 3 months and not planning to undergo therapy adjustment during trial
Exclusion criteria
* Chronic kidney disease (glomerular filtration rate (GFR) \< 60 mL/min/1.73 m² for 3 months or more), due to its potential impact on serum biomarker clearance * Other primary sleep disorders aside from OSA (i.e., narcolepsy, REM Sleep behavior disorder, chronic insomnia, restless legs syndrome), circadian rhythm disorder or shift work * Chronic neurological disorders (e.g. Multiple sclerosis, epilepsy, neurodegenerative disorders, ALS), due to their impact on biomarkers. History of headache (\<15 days a month) and stroke (over 6 months prior to enrollment) are allowed * Physical limitations preventing the use of Neuroglide device (e.g. inability to lay on the back due to pain, inability to setup the device due to limb dysfunction/weakness) * Physical limitations preventing the use or function of Somfit, including forehead skin lesions, history of adhesive allergies, implanted electronic devices (e.g. pacemakers) or the use of CPAP masks with forehead support/bar/pad (Fisher \& Paykel Vitera, Fisher \& Paykel Eson, ResMed Mirage Quattro, ResMed Ultra Mirage Full Face Mask, Philips Respironics ComfortGel Blue), because the forehead piece of the mask would prevent the appropriate application of Somfit for at-home sleep monitoring. Because Somfit algorithms are based on physiological signals that include heart rate and it has not been validated in patients with persistent arrhythmia, we will exclude patients with history of atrial fibrillation and high PVC burden to avoid inaccurate estimates. * Acute cardiopulmonary disorders, infections, injury at/near the application site, abnormal lymphatic system due to previous surgery involving lymphatics or chronic lymphedema, acute inflammatory process (e.g. recent knee/hip surgery, upper respiratory tract infection, cancer not in remission) * Kokmen short test of mental status \< 34 (concern for mild cognitive impairment) * Inability to comply with study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in serum biomarkers | Baseline and Day 31 | Samples will be processed and tested for: * Aβ42 * Aβ40 * Aβ42/Aβ40 ratio * Phospho-tau 217 (p-tau-217) * Neurofilament light chain (NfL) * Glial fibrillary acidic protein (GFAP) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Differences in Pittsburgh Sleep Quality Index (PSQI) | Baseline and Day 31 | Differences in Pittsburgh Sleep Quality Index (PSQI) scores. Scoring ranges from 0-21 with higher scores indicating poorer sleep quality. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDiego Zaquera Carvalho, M.D., M.S.
Mayo Clinic
Outcome results
None listed