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NCT07301762

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

Enrolling by Invitation
NAAges 50+Interventional
Mayo Clinic
~12 participants
Updated 2025-12-24 on ClinicalTrials.gov
What's tested:Automated manual lymphatic drainage therapy (AMLDT) device

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Difference in serum biomarkers
Measured over Baseline and Day 31

Conditions

Obstructive Sleep Apnea (OSA)
OSA
Obstructive Sleep Apnea

Explore related trials

Obstructive Sleep Apnea

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Diego Zaquera Carvalho, M.D., M.S. · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Difference in serum biomarkersBaseline 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)