A Study Of Automated Manual Lymphatic Drainage Therapy For Obstructive Sleep Apnea

Overview

About this study

The purpose of this study is to evaluate whether enhancing systemic lymphatic drainage using an automated manual lymphatic drainage therapy (AMLDT) device7 can improve glymphatic clearance in patients with OSA, as measured by changes in serum biomarkers related to AD pathology (Aβ42, Aβ40, Aβ42/Aβ40 ratio, and p-tau-217), neurodegeneration/white matter integrity (neurofilament light chain), and neuroinflammation (glial fibrillary acidic protein). The AMLDT device (Neuroglide) is a FDA-cleared Class II medical device (K202693) for over-the-counter use for pain.8 It mimics manual lymphatic drainage through a pneumatic mat that performs rhythmic inflation and deflation in ascending fashion.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Adult patients aged 50 years and older who have been diagnosed with obstructive sleep apnea (OSA) and have been on stable, effective, and compliant CPAP therapy for a minimum of 6-months. Participants must be able to provide informed consent and be willing to use automated manual lymphatic drainage device (Neuroglide) nightly for 1-month and participate in at-home sleep monitoring.

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).

  • 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.

  • Inability to comply with study procedures.

  • 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)

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 7/18/2025. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Diego Zaquera Carvalho

Open for enrollment

Contact information:

Pulmonary Clinical Research Unit

(800) 753-1606

PCRUE18@mayo.edu

More information

Publications

Publications are currently not available