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Enrolling by invitation NCT07301762

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

No phase Interventional Obstructive Sleep Apnea (OSA) OSA Obstructive Sleep Apnea

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Automated manual lymphatic drainage therapy (AMLDT) device.
Who it may be relevant to
Registry conditions: Obstructive Sleep Apnea (OSA), OSA, Obstructive Sleep Apnea. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Difference in serum biomarkers [Time frame: Baseline and Day 31]
Secondary outcome measures (1)
  • Differences in Pittsburgh Sleep Quality Index (PSQI) [Time frame: Baseline and Day 31]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • Mayo Clinic — Rochester

Identifiers

NCT: NCT07301762 · 25-008009

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗