Is NCT06519149 recruiting in Austin, TX?

Yes, NCT06519149 is currently recruiting participants at its Austin, TX location. This obstructive sleep apnea clinical trial is actively enrolling qualified participants.

How do I join the obstructive sleep apnea clinical trial in Austin?

To join this clinical trial in Austin, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Austin clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Obstructive Sleep Apnea Clinical Trial in Austin, TX

About This Obstructive Sleep Apnea Study in Austin

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.

Sponsor: Slow Wave, Inc.

Who Can Participate

Inclusion Criteria

• 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

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

Exclusion Criteria

• 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.

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Austin?

Yes, this clinical trial (NCT06519149) has an active research site in Austin, TX that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Obstructive Sleep Apnea Treatment Options in Austin, TX

If you're searching for obstructive sleep apnea treatment options in Austin, TX, this clinical trial (NCT06519149) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Austin research site is actively enrolling participants for this clinical trial. You'll receive care from experienced obstructive sleep apnea specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all obstructive sleep apnea clinical trials near you to find additional studies recruiting in your area.

Obstructive Sleep Apnea Clinical Trial in Austin, TX

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