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

Mayo Clinic

Status

Invitation-only

Conditions

Obstructive Sleep Apnea (OSA)

OSA

Obstructive Sleep Apnea

Treatments

Device: Automated manual lymphatic drainage therapy (AMLDT) device

Study type

Interventional

Funder types

Other

Identifiers

NCT07301762

25-008009

Details and patient eligibility

About

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

Full 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.

Enrollment

12 estimated patients

Sex

All

Ages

50+ years old

Volunteers

No 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