A Phase 4 interventional study of Positive airway pressure (PAP) therapy and Sleep dental device in Obstructive Sleep Apnea (OSA), sponsored by Sairam Parthasarathy. Recruiting at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Sairam Parthasarathy · Phase 4, Interventional, and Treatment
Researchers want to identify which treatments for obstructive sleep apnea (OSA) work best and are easiest for patients to use consistently. Eligible participants will be randomly assigned one of three OSA treatments: traditional PAP therapy, a dental device, or a combination of two FDA-approved medications (atomoxetine and oxybutynin) that are currently approved for other conditions. Over the course of one year, participants will attend two in-person visits and take part in four phone check-ins to complete surveys, report any side effects, and discuss how well they are following their assigned treatment.
2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.
This study's planned enrollment of 2,400 is above the median of 52 across 1,472 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →Sairam Parthasarathy is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will use a PAP machine to treat their obstructive sleep apnea.
Device: Positive airway pressure (PAP) therapy
Participants will use a sleep dental device to treat their obstructive sleep apnea.
Device: Sleep dental device
Participants will use the medication combination of atomoxetine-oxybutynin to treat their obstructive sleep apnea.
Drug: Atomoxetine-oxybutynin
Positive airway pressure delivered via a nasal or face mask while a patient sleeps to keep the airways open.
Also known as: CPAP
An oral appliance worn during sleep to move the lower jaw forward, which tightens soft tissues and widens the airway to prevent sleep apnea.
Also known as: Mandibular advancement device (MAD)
The combination of two medications (atomoxetine-oxybutynin) can reduce obstructive sleep apnea by increasing upper airway muscle activity.
Health-related quality of life
To compare the effectiveness of positive airway pressure (PAP) therapy versus dental device versus atomoxetine-oxybutynin for key patient centered outcomes in improving health-related quality of life over 12 months, as assessed by the PROMIS-29 v2.0.
Time frame: At 12 months
OSA treatment effectiveness - Effective AHI score
To compare the effectiveness of PAP therapy versus dental device versus atomoxetine-oxybutynin for treatment of OSA over 12 months, assessed by the effective apnea hypopnea index (AHI). Effective AHI equals the sum of apneas and hypopneas with treatment and without treatment divided by hours of total sleep time.
Time frame: 12 months
OSA treatment effectiveness - PROMIS-Sleep Related Impairment 8a
To compare the effectiveness of PAP therapy versus dental device versus atomoxetine-oxybutynin for treatment of OSA over 12 months, assessed via the PROMIS-Sleep Related Impairment 8a.
Time frame: 12 months
Changes in systolic blood pressure
To compare the effectiveness of PAP therapy versus dental device versus atomoxetine-oxybutynin in improving systolic blood pressure (mmHg) over 12 months.
Time frame: 12 months
Changes in diastolic blood pressure
To compare the effectiveness of PAP therapy versus dental device versus atomoxetine-oxybutynin in improving diastolic blood pressure (mmHg) over 12 months.
Time frame: 12 months
OSA treatment adherence
To compare treatment adherence (defined as % of nights assigned treatment was used for 4 or more hours) between PAP therapy versus dental device versus atomoxetine-oxybutynin.
Time frame: 12 months
Adverse effects of OSA treatment
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Time frame: 12 months
Change From Baseline in PROMIS Sleep Disturbance v2.0 T-Score at 12 Months
Sleep disturbance will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance v2.0 scale. The outcome measure is change in PROMIS Sleep Disturbance T-score from baseline to 12 months. PROMIS Sleep Disturbance scores are standardized T-scores referenced to the U.S. general population (mean=50; SD=10) and range from \~ 20 to 80, with higher scores indicating greater sleep disturbance and worse sleep-related symptoms. Negative values for change from baseline indicate improvement in sleep disturbance. Predictors of treatment response will be evaluated using multivariable logistic regression. The dependent variable will be achievement of a clinically meaningful improvement in PROMIS Sleep Disturbance T-score (MCID responder status). Determinants include treatment assignment, age, sex, race/ethnicity, socioeconomic status, insurance status, baseline sleep apnea severity, obesity, \& other prespecified determinants.
Time frame: 12 months
Plan to share: Yes — De-identified outcomes data, including a data dictionary will be made available.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: One year after the primary paper has been accepted and secondary paper has been submitted. Data will be available for as long as Dr. Parthasarathy is with the University of Arizona.
Access criteria: Researchers that contact the primary PI (S. Parthasarathy, MD) with a proposal to use the data and complete a data use agreement with the University of Arizona.
Data sharing details ↗ · sleep.arizona.edu
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Sairam Parthasarathy