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Automated Manual Lymphatic Drainage Therapy to Improve Glymphatic Function in OSA Patients | Clinical Trials | Clareo Health

ENROLLING_BY_INVITATIONNA

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

NCT07301762•Mayo Clinic

View on ClinicalTrials.gov

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.

Eligibility

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Mayo Clinic

Rochester, Minnesota, United States

Key Dates

Start Date

November 24, 2025

Primary Completion Date

June 1, 2026

Completion Date

June 1, 2026

Last Updated

December 24, 2025

Enrollment

ESTIMATED participants

Conditions

Obstructive Sleep Apnea (OSA)OSAObstructive Sleep Apnea

Interventions

Automated manual lymphatic drainage therapy (AMLDT) device

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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