Obstructive Sleep Apnea (OSA)NCT07301762
Automated Manual Lymphatic Drainage Therapy to Improve Glymphatic Function in OSA Patients
A study testing Automated manual lymphatic drainage therapy (AMLDT) device in people with Obstructive Sleep Apnea (OSA) and OSA, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research is to investigate whether enhancing systemic lymphatic drainage improves glymphatic function in patients with obstructive sleep apnea (OSA). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Obstructive Sleep Apnea (OSA), OSA, Obstructive Sleep Apnea
- What is being tested?
- Automated manual lymphatic drainage therapy (AMLDT) device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Nov 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Using Automated Manual Lymphatic Drainage Therapy to Optimize Glymphatic Function in Patients With Obstructive Sleep Apnea: Proof-of-Concept Open-Label Trial
The purpose of this research is to investigate whether enhancing systemic lymphatic drainage improves glymphatic function in patients with obstructive sleep apnea (OSA).
Read the 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.
- Conditions
- Obstructive Sleep Apnea (OSA), OSA, Obstructive Sleep Apnea
- Being tested
- Automated manual lymphatic drainage therapy (AMLDT) device
- Keywords
- obstructive sleep apnea, OSA
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated manual lymphatic drainage therapy (AMLDT) deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | Open-Label intervention Receives: Device: Automated manual lymphatic drainage therapy (AMLDT) device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline and Day 31
Secondary outcomes (1)
Differences in Pittsburgh Sleep Quality Index (PSQI)
Differences in Pittsburgh Sleep Quality Index (PSQI) scores. Scoring ranges from 0-21 with higher scores indicating poorer sleep quality.
Measured: Baseline and Day 31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start24 Nov 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea (OSA)Studies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diego Zaquera Carvalho, Mayo Clinic
- Investigators
- Diego Zaquera Carvalho, M.D., M.S., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07301762
- Sponsor's protocol ID
- 25-008009
- Status last verified
- Sep 2026
- First submitted
- 21 Dec 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Automated Manual Lymphatic Drainage Therapy to Optimize Glymphatic Function in Patients With Obstructive Sleep Apnea: Proof-of-Concept Open-Label Trial
- ClinicalTrials.gov ID
- NCT07301762
- Acronym / sponsor ID
- 25-008009
- Conditions
- Obstructive Sleep Apnea (OSA), OSA, Obstructive Sleep Apnea
- Keywords
- obstructive sleep apnea, OSA
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 24 Nov 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Device: Automated manual lymphatic drainage therapy (AMLDT) deviceOpen-Label intervention |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automated manual lymphatic drainage therapy (AMLDT) deviceThe 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. | Device | Intervention |
Primary outcome
Difference in serum biomarkers
Time frame: Baseline 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)
1 secondary outcome
Differences in Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline and Day 31
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Diego Zaquera Carvalho, M.D., M.S. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated manual lymphatic drainage therapy (AMLDT) device in people with Obstructive Sleep Apnea (OSA) and OSA, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in serum biomarkers (time frame: Baseline and Day 31). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.