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

NCT07301762 | Enrolling By Invitation FDA Device

• 1 other identifier: 25-008009
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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).

Conditions

Obstructive Sleep Apnea (OSA); OSA; Obstructive Sleep Apnea

Keywords

obstructive sleep apnea; OSA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Differences in Pittsburgh Sleep Quality Index (PSQI)

  Baseline and Day 31

Other Outcomes (1)

• Differences in sleep macro-structure and microstructure

  Baseline and Day 31

Study Arms (1)

Intervention

OTHER

Open-Label intervention

Device: Automated manual lymphatic drainage therapy (AMLDT) device

Interventions

Automated manual lymphatic drainage therapy (AMLDT) device 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.

Intervention

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Diego Zaquera Carvalho, M.D., M.S.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 21, 2025
• First Posted: December 24, 2025
• Study Start: November 24, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)