Automated Manual Lymphatic Drainage Therapy to Improve Glymphatic Function in OSA Patients

Using Automated Manual Lymphatic Drainage Therapy to Optimize Glymphatic Function in Patients With Obstructive Sleep Apnea: Proof-of-Concept Open-Label Trial

The purpose of this research is to investigate whether enhancing systemic lymphatic drainage improves glymphatic function in patients with obstructive sleep apnea (OSA).

Study Overview

• Status: Enrolling by invitation
• Conditions: Obstructive Sleep Apnea; OSA; Obstructive Sleep Apnea (OSA)
• Intervention / Treatment: Device: Automated manual lymphatic drainage therapy (AMLDT) device

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.

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Intervention; Open-Label intervention	Device: Automated 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in serum biomarkers	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)	Baseline and Day 31

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in Pittsburgh Sleep Quality Index (PSQI)	Differences in Pittsburgh Sleep Quality Index (PSQI) scores. Scoring ranges from 0-21 with higher scores indicating poorer sleep quality.	Baseline and Day 31

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in sleep macro-structure and microstructure	Assessment of correlation between changes in sleep macrostructure (Nonrapid eye movement sleep stages 1-3 [%], sleep duration [minutes], sleep efficiency [%]) and microstructure (power spectral density of slow wave activity [µV²/Hz]) and changes in serum biomarkers (1-42/1-40 [ratio], pTau181 [pg/mL], neurofilament light chain [pg/mL], and GFAP [pg/mL] ).	Baseline and Day 31

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Diego Zaquera Carvalho, M.D., M.S., Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: December 21, 2025
• First Submitted That Met QC Criteria: December 23, 2025
• First Posted (Actual): December 24, 2025

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 23, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: OSA; obstructive sleep apnea
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: 25-008009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No