Obstructive Sleep ApneaNCT06519149
Safety and Effectiveness of Slow Wave Device for the Treatment of Obstructive Sleep Apnea
An observational study of Obstructive Sleep Apnea, run by Slow Wave, Inc. at 1 site in United States.
Trial summary
This is a safety and efficacy trial for a Slow Wave, Inc. UASD oral appliance for the treatment of Obstructive Sleep Apnea. This trial will recruit 60-80 participants through our IRB partner. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Slow Wave UASD
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to 30 Sep 2025
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals with mild-to-moderate OSA and individuals with severe OSA below and AHI of 40 who cannot tolerate CPAP treatment
Who may be able to join
- • Provision of signed and dated informed consent form
- Unable to tolerate or decline positive airway pressure therapy
- Absence of markedly enlarged tonsils, defined as 3+ or 4+ according to the Brodsky classification
- Able to protrude tongue ≥20mm beyond maxillary incisors
- No uncontrolled nasal obstruction (must be able to breathe through nose)
- Stable medication regimen for ≥1 month
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- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, of any race, aged 18-70 years (inclusive)
- If diagnosed with uncomplicated Mild to moderate, moderate to severe OSA (i.e., AHI >5, <30 h-1); where uncomplicated is defined by the absence of:
- Conditions that place the patient at increased risk of non-obstructive sleep-disordered breathing (e.g., central sleep apnea, hypoventilation, and sleep-related hypoxemia). Examples of such conditions include significant cardiopulmonary disease, potential respiratory muscles weakness due to neuromuscular conditions, history of stroke, and chronic opiate medication use.
- Concern for significant non-respiratory sleep disorder(s) that require evaluation (e.g., disorders of central hypersomnolence, parasomnias, sleep-related movement disorders) or interfere with accuracy of HSAT (e.g., severe insomnia).
- Environmental or personal factors that preclude the adequate acquisition and interpretation of data from HSAT.
- Body mass index (BMI) < 35 kg/m2
- Neck circumference < 45 cm
- Absence of severe oxyhemoglobin desaturation during sleep, indicated by mean nocturnal SpO2 > 82%
- Mandibular range of motion > 5 mm in protrusive direction
- Adequate dentition, as determined by the site dentist
- Must have a smart phone able to download 02 ring app
Who cannot join
- • Inability to breathe through the nose comfortably
- Presence of > 25% Central Sleep Apnea (CSA)
- Severe OSA above AHI >40
- Uncontrolled sleep disorder such as narcolepsy, chronic insomnia, restless legs syndrome, or REM behavior disorder
- Presence of positional obstructive sleep apnea per Cartwright's definition (Ratio of respiratory events in the supine to nonsupine position greater than 2:1)
- History of surgery intended to alter anatomy for the correction of OSA, such as uvulopalatopharyngoplasty (UPPP), maxillomandibular advancement (MMA), or tongue/hyoid suspension.
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- History of surgery intended to restore normal anatomy, such as tonsillectomy, adenoidectomy, septoplasty, or polypectomy within the previous 6 months
- Presence of hypoglossal nerve stimulation device
- Use of CPAP or OAT within the two weeks prior to the screening HSAT
- Anticipated change in medical therapy during the study protocol that could alter OSA severity (e.g., weight loss surgeries; UPPP, MMA, tongue/hyoid suspension)
- Loose teeth or advanced periodontal disease
- Teeth extractions/Presence of a dental post implanted less than 12 months
- Removable dentures
- History of temporomandibular joint disorder (TMJ)
- Resistant hypertension, defined as inadequately controlled blood pressure despite therapy with ≥ 3 oral hypertensive agents
- Presence of congestive heart failure (NYHA Class IV), persistent/permanent atrial fibrillation, or acute coronary artery disease (STEMI/NSTEMI/USA) in the past 30 days.
- Presence of neuromuscular diseases e.g. myasthenia gravis, amyotrophic lateral sclerosis, Guillain-Barré syndrome and muscular dystrophy, or hypoventilation disorders which results in shallow breathing during sleep and/or cyanosis of the fingers/toes.
- Presence of pulmonary disease resulting in significant desaturation, e.g., severe chronic obstructive pulmonary disease, interstitial lung disease (SaO2 nadir of 87%), or pulmonary hypertension
- History of cerebrovascular incident within the last 12 months
- Use of pacemaker or other life supporting device
- Anticipated change in body weight > 5% during the study period
- Participation in other studies that could interfere with the study protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Austin Heart Research
Austin, Texas, 78705
Hanna Mendyuk, RN, 512-421-3896, hanna.mendyuk@HCAhealthcare.com
Angela Dela Llana, RN, (512) 953-1511, Angela.DelaLlana@HCAHealthcare.com
About this study
This is a safety and efficacy trial for a Slow Wave, Inc. UASD oral appliance for the treatment of Obstructive Sleep Apnea. This trial will recruit 60-80 participants through our IRB partner. Each participant will take pre-trial and post trail sleep studies and be measured before, throughout and after the trial for Apnea-Hypopnea Index (AHI), Oxygen Desaturation Index (ODI), pulse rate to determine level of sleep improvement while wearing the device. Safety will also be measured through survey, dental exams and adverse events monitoring. Patients will wear an O2 monitoring ring throughout the study and upload results daily. Primary Objectives will evaluate AHI and ODI between sleep studies. Secondary outcomes will compare the daily ring data to these two sleep studies to evaluate changes over time. Patients will have the opportunity to complete daily diaries on their sleep experiences.
Read the detailed description
This study is a single-center, single-arm open label study to evaluate the safety and effectiveness of the Slow Wave UASD sleep and snore device in individuals with mild-to-moderate Obstructive Sleep Apnea (OSA) and individuals with severe OSA of less than 40 AHI events per hour who are not able to tolerate CPAP treatment.
All participants will be given and initial Home Sleep Apnea Test (HSAT) to establish baseline readings for: Number of OSA events during sleep, average O2 score during sleep, average pulse rate and Oxygen desaturation events of more than 4% during sleep (ODI). The initial HSAT will also determine if the patients have OSA.
All participants will get an intraoral scan with a closed bite by a study partner. The 3D scan will be used to create a personalized Slow Wave UASD device that will be used throughout the study. Each participant will wear the device for a 90-day period. Each participant will be given a WellUE O2 ring to wear every night throughout the study. The ring connects to the WellUE application that participants will be asked to download to their phones. The O2 ring application collects much of hte same data as is collected in a home sleep study. Participants will be asked to upload the ring results to a study-managed database on a daily basis. Ring results will be presented as secondary objectives in this trial. The failure of a participant to send ring data will not disqualify them from the trial as primary objectives are the comparison of beginning and ending HSAT results. Patients will be given patient health questionnaires and physical examinations prior to participation.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Slow Wave UASD
- 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.
Slow Wave UASDDevice
Also called Slow Wave Oral appliance for the treatment of OSA
An oral appliance for the treatment of OSA and snoring
| Study group | Role | What they receive |
|---|---|---|
| Slow Wave UASD | Participants who wear the Slow Wave UASD oral device fora 90 day period and a Wellue O2 ring to measure daily sleep metrics Receives: Device: Slow Wave UASD |
What is being measured
The primary outcome is the main question the study is designed to answer.
AHI Events per hour
A 50% or greater reduction in apnea-hypopnea index (AHI) events from the baseline reading while wearing the device
Measured: 90 days
Oxygen Desaturation events during sleep
a 25% or greater decrease in events where oxygen desaturation is greater than or equal to 4% during sleep while wearing the device
Measured: 90 days
Device safety and comfort
All reported adverse events and patient input of side effects, dental exams and surveys
Measured: 90 days
Secondary outcomes (3)
Efficacy Ring Comparison
comparing baseline and ending HSAT sleep study results to collected patient ring data
Measured: 90 days
Pulse rate
effect on pulse rate while wearing the appliance
Measured: 90 days
Device safety and comfort
development of adverse events and development of any side effects over time.
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start1 Oct 2024
- Primary completion21 Aug 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Slow Wave, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- St. David's HealthCare
- Responsible party
- Sponsor
- Investigators
- Matthew Jepson, MD, Principal investigator, St. David's HealthCareNirman Koladia, MD, Study director, Clinical Research Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06519149
- Sponsor's protocol ID
- 2192249-1
- Status last verified
- Apr 2025
- First submitted
- 19 Jul 2024
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Varghese L, Rebekah G, N P, Oliver A, Kurien R. Oxygen desaturation index as alternative parameter in screening patients with severe obstructive sleep apnea. Sleep Sci. 2022 Jan-Mar;15(Spec 1):224-228. doi: 10.5935/1984-0063.20200119.
PubMed 35273770Temirbekov D, Gunes S, Yazici ZM, Sayin I. The Ignored Parameter in the Diagnosis of Obstructive Sleep Apnea Syndrome: The Oxygen Desaturation Index. Turk Arch Otorhinolaryngol. 2018 Mar;56(1):1-6. doi: 10.5152/tao.2018.3025. Epub 2018 Mar 1.
PubMed 29988275Cartwright RD. Effect of sleep position on sleep apnea severity. Sleep. 1984;7(2):110-4. doi: 10.1093/sleep/7.2.110.
PubMed 6740055
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Slow Wave Device for the Treatment of Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT06519149
- Acronym / sponsor ID
- 2192249-1
- Conditions
- Obstructive Sleep Apnea
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Slow Wave, Inc.Industry (pharma, biotech, devices)
- Collaborators
- St. David's HealthCare
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 21 Aug 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 25 Jul 2024 (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.
This is a safety and efficacy trial for a Slow Wave, Inc. UASD oral appliance for the treatment of Obstructive Sleep Apnea. This trial will recruit 60-80 participants through our IRB partner. Each participant will take pre-trial and post trail sleep studies and be measured before, throughout and after the trial for Apnea-Hypopnea Index (AHI), Oxygen Desaturation Index (ODI), pulse rate to determine level of sleep improvement while wearing the device. Safety will also be measured through survey, dental exams and adverse events monitoring. Patients will wear an O2 monitoring ring throughout the study and upload results daily. Primary Objectives will evaluate AHI and ODI between sleep studies. Secondary outcomes will compare the daily ring data to these two sleep studies to evaluate changes over time. Patients will have the opportunity to complete daily diaries on their sleep experiences.
Detailed description
This study is a single-center, single-arm open label study to evaluate the safety and effectiveness of the Slow Wave UASD sleep and snore device in individuals with mild-to-moderate Obstructive Sleep Apnea (OSA) and individuals with severe OSA of less than 40 AHI events per hour who are not able to tolerate CPAP treatment.
All participants will be given and initial Home Sleep Apnea Test (HSAT) to establish baseline readings for: Number of OSA events during sleep, average O2 score during sleep, average pulse rate and Oxygen desaturation events of more than 4% during sleep (ODI). The initial HSAT will also determine if the patients have OSA.
All participants will get an intraoral scan with a closed bite by a study partner. The 3D scan will be used to create a personalized Slow Wave UASD device that will be used throughout the study. Each participant will wear the device for a 90-day period. Each participant will be given a WellUE O2 ring to wear every night throughout the study. The ring connects to the WellUE application that participants will be asked to download to their phones. The O2 ring application collects much of hte same data as is collected in a home sleep study. Participants will be asked to upload the ring results to a study-managed database on a daily basis. Ring results will be presented as secondary objectives in this trial. The failure of a participant to send ring data will not disqualify them from the trial as primary objectives are the comparison of beginning and ending HSAT results. Patients will be given patient health questionnaires and physical examinations prior to participation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Slow Wave UASD | – | Device: Slow Wave UASDParticipants who wear the Slow Wave UASD oral device fora 90 day period and a Wellue O2 ring to measure daily sleep metrics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with mild-to-moderate OSA and individuals with severe OSA below and AHI of 40 who cannot tolerate CPAP treatment
Key inclusion criteria (18 listed)
- • Provision of signed and dated informed consent form
Key exclusion criteria (22 listed)
- • Inability to breathe through the nose comfortably
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 |
|---|---|---|
| Slow Wave UASDAlso: Slow Wave Oral appliance for the treatment of OSAAn oral appliance for the treatment of OSA and snoring | Device | Slow Wave UASD |
Primary outcome
AHI Events per hour
Time frame: 90 days
A 50% or greater reduction in apnea-hypopnea index (AHI) events from the baseline reading while wearing the device
Oxygen Desaturation events during sleep
Time frame: 90 days
a 25% or greater decrease in events where oxygen desaturation is greater than or equal to 4% during sleep while wearing the device
Device safety and comfort
Time frame: 90 days
All reported adverse events and patient input of side effects, dental exams and surveys
3 secondary outcomes
Efficacy Ring Comparison
Time frame: 90 days
Pulse rate
Time frame: 90 days
Device safety and comfort
Time frame: 120 days
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 23 Apr 2025.
- Results publication: PubMed 35273770Varghese L, Rebekah G, N P, Oliver A, Kurien R. Oxygen desaturation index as alternative parameter in screening patients with severe obstructive sleep apnea. Sleep Sci. 2022 Jan-Mar;15(Spec 1):224-228. doi: 10.5935/1984-0063.20200119.
- Results publication: PubMed 29988275Temirbekov D, Gunes S, Yazici ZM, Sayin I. The Ignored Parameter in the Diagnosis of Obstructive Sleep Apnea Syndrome: The Oxygen Desaturation Index. Turk Arch Otorhinolaryngol. 2018 Mar;56(1):1-6. doi: 10.5152/tao.2018.3025. Epub 2018 Mar 1.
- Results publication: PubMed 6740055Cartwright RD. Effect of sleep position on sleep apnea severity. Sleep. 1984;7(2):110-4. doi: 10.1093/sleep/7.2.110.
- Market sizing information on OSALink provided by the sponsor.
- 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.
Matthew Jepson, MD principal investigator
St. David's HealthCare
Nirman Koladia, MD study director
Clinical Research Consultant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by Slow Wave, Inc. 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 18 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 23 Apr 2025. 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?
Contact Bill S Morris (5124663977, bmorris@slowwave.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AHI Events per hour (time frame: 90 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06519149, which also lists 3 linked publications.
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 23 Apr 2025.