A Phase 1/2 interventional study of Combination device and drug: Unilateral hypoglossal nerve stimulation & atomoxetine-plus-oxybutynin (HGNS+AtoOxy) and Unilateral hypoglossal nerve stimulation (HGNS), active comparator condition in Obstructive Sleep Apnea and Sleep-disordered Breathing, sponsored by Brigham and Women's Hospital. Recruiting at 1 site in United States. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Brigham and Women's Hospital · Phase 1/2, Interventional, and Treatment
Among 42 studies in Sleep Apnea, Obstructive by Brigham and Women's Hospital — 12 open to participants now, 12 under way, none of them phase 3. Sleep Apnea, Obstructive · Brigham and Women's Hospital.
Among the 42 studies in Sleep Apnea, Obstructive by Brigham and Women's Hospital, this one is the 20th largest by planned enrollment, is one of 4 that started in 2026, is one of 13 in phase 1/2, reaches primary completion later than 9 of the 11 other live ones, and was the 40th registered.
2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.
Browse Sleep Apnea, Obstructive studies →12 of the 42 studies in Sleep Apnea, Obstructive by Brigham and Women's Hospital are open now, in 1 country. Recruiting first, the newest first:
Brigham and Women's Hospital · Sites in United States
Brigham and Women's Hospital · Sites in United States
Brigham and Women's Hospital · Sites in United States
Brigham and Women's Hospital · Sites in United States
Brigham and Women's Hospital · Sites in United States
By country, each count listing its studies:
Of the 313 Sleep Apnea, Obstructive studies recruiting now, 145 (46%) set no upper age limit and 125 (40%) stop at 75 or younger; 53 take children under 18; 65 take healthy volunteers.
This study: 18 Years to 79 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
42 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 15 · Phase 2 21
First in 2004; this study’s year is marked. 4 started in 2026.
This study's planned enrollment of 24 is below the median of 52 across 1,472 interventional studies indexed under Sleep Apnea, Obstructive.
Median enrollment 22 across the 42 interventional studies. Of the 28 that completed or were terminated, 18 (64%) have results posted.
This tab as a report to print or save as PDF → With an account.
Brigham and Women's Hospital is the lead sponsor of 1,267 studies on the registry; 228 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.
3 of the studies in Sleep Apnea, Obstructive by Brigham and Women's Hospital that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05350215Brigham and Women's HospitalAtomoxetine and DAW2022 on OSA Severity | 2026-12-01 |
| NCT06854211Brigham and Women's HospitalImpacts of Opioids on Respiratory Drive During Sleep | 2027-01-01 |
| NCT06043440Brigham and Women's HospitalDown Syndrome Obstructive Sleep Apnea | 2027-11-30 |
Among the 42 studies in Sleep Apnea, Obstructive by Brigham and Women's Hospital, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Obstructive sleep apnea (OSA) is a common condition in which the airway repeatedly collapses during sleep, leading to poor sleep quality and reduced oxygen levels. Hypoglossal nerve stimulation (HGNS) is an approved treatment that uses a small implanted device to stimulate the genioglossus muscle and keep the airway open. However, some patients continue to have OSA despite using HGNS. Atomoxetine and oxybutynin, "AtoOxy", is a promising pharmacologcal therapy under investigation that has been shown to activate pharyngeal muscles-in particular non-genioglossus muscles--but appears more efficacious in some patients than others.
This study will test whether the combination of AtoOxy and HGNS can further improve breathing during sleep compared to either monotherapy alone. Participants with OSA and an HGNS device will be randomized to receive, in random order: HGNS+AtoOxy, HGNS alone (plus placebo), AtoOxy alone (HGNS device off), and placebo (HGNS device off), in a cross-over trial.
The main goal is to determine whether the combined treatment reduces the number of breathing events during sleep; the primary outcome test will compare HGNS+AtoOxy versus HGNS alone. The effect of each intervention versus placebo will also be presented.
The study will also examine how individual patient characteristics influence response to treatment.
Residual obstructive sleep apnea (OSA) is common among patients treated with hypoglossal nerve stimulation (HGNS), reflecting incomplete correction of underlying pathophysiological traits. In addition to upper airway collapsibility, non-anatomical factors such as a low arousal threshold may contribute to persistent disease despite HGNS therapy. Pharmacologic modulation of these traits represents a potential strategy to enhance treatment efficacy.
Atomoxetine (a norepinephrine re-uptake inhibitor) and oxybutynin (an anti-muscarinic agent) have been shown to increase upper airway muscle tone and raise the arousal threshold, leading to reductions in OSA severity in prior studies. However, their combined effect when added to ongoing HGNS therapy has not been systematically evaluated.
This study is a randomized, placebo-controlled, crossover trial designed to assess the acute effects of combined pharmacologic and electrical stimulation on OSA severity. Participants with OSA who are already implanted with HGNS, or pending clinical implantation, will be enrolled in a four-period randomized placebo-controlled cross-over trial assessing HGNS+AtoOxy, HGNS alone (plus placebo), AtoOxy alone (HGNS device off), and placebo (HGNS device off).
The main goal is to determine whether the combined treatment reduces the number of breathing events during sleep; the primary outcome test will compare HGNS+AtoOxy versus HGNS alone. The effect of each intervention versus placebo will also be presented.
Polysomnographic measurements will be also be used to explore mechanisms underlying response, including the interaction between pharmacologically modifiable traits and HGNS-mediated airway stabilization. Additional analyses will evaluate whether baseline physiological characteristics predict treatment response, with the goal of informing personalized treatment strategies for patients with residual OSA. Patient-reported outcomes, including sleepiness, sleep-related quality of life, fatigue, and treatment satisfaction, will also be assessed to evaluate the broader clinical impact of the combination intervention.
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:
Issues relating to short-term withdrawal of HGNS therapy
chronic hypoventilation/hypoxemia (awake SaO2 \< 92% by oximetry) due to or other respiratory conditions.
for atomoxetine and oxybutynin, including:
suspected benign prostatic hypertrophy / urinary retention based on a positive answer to either of the following questions:
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.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
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.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
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.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HGNS+AtoOxy -\> Placebo -\> HGNS -\> AtoOxy Each participant receives all four treatment conditions ("periods") in randomized order; outcomes are analyzed as within-subject comparisons, not between sequence arms.
Other: Combination device and drug: Unilateral hypoglossal nerve stimulation & atomoxetine-plus-oxybutynin (HGNS+AtoOxy) · Device: Unilateral hypoglossal nerve stimulation (HGNS), active comparator condition · Drug: Atomoxetine-plus-oxybutynin (80/5 mg) (AtoOxy), active comparator condition · Drug: Placebo; placebo comparator condition
HGNS -\> AtoOxy -\> HGNS+AtoOxy -\> Placebo Each participant receives all four treatment conditions ("periods") in randomized order; outcomes are analyzed as within-subject comparisons, not between sequence arms.
Other: Combination device and drug: Unilateral hypoglossal nerve stimulation & atomoxetine-plus-oxybutynin (HGNS+AtoOxy) · Device: Unilateral hypoglossal nerve stimulation (HGNS), active comparator condition · Drug: Atomoxetine-plus-oxybutynin (80/5 mg) (AtoOxy), active comparator condition · Drug: Placebo; placebo comparator condition
AtoOxy -\> HGNS -\> Placebo -\> HGNS+AtoOxy Each participant receives all four treatment conditions ("periods") in randomized order; outcomes are analyzed as within-subject comparisons, not between sequence arms.
Other: Combination device and drug: Unilateral hypoglossal nerve stimulation & atomoxetine-plus-oxybutynin (HGNS+AtoOxy) · Device: Unilateral hypoglossal nerve stimulation (HGNS), active comparator condition · Drug: Atomoxetine-plus-oxybutynin (80/5 mg) (AtoOxy), active comparator condition · Drug: Placebo; placebo comparator condition
Placebo -\> HGNS+AtoOxy -\> AtoOxy -\> HGNS Each participant receives all four treatment conditions ("periods") in randomized order; outcomes are analyzed as within-subject comparisons, not between sequence arms.
Other: Combination device and drug: Unilateral hypoglossal nerve stimulation & atomoxetine-plus-oxybutynin (HGNS+AtoOxy) · Device: Unilateral hypoglossal nerve stimulation (HGNS), active comparator condition · Drug: Atomoxetine-plus-oxybutynin (80/5 mg) (AtoOxy), active comparator condition · Drug: Placebo; placebo comparator condition
Electrical stimulation of the hypoglossal nerve using an implanted device (Inspire Medical Systems) to activate upper airway dilator muscles during sleep at prescribed therapeutic settings. Atomoxetine 80 mg administered orally at bedtime. Oxybutynin 5 mg administered orally at bedtime. Dose escalation with half-dose for initial 3 nights followed by full dose.
Also known as: HGNS+AtoOxy
Electrical stimulation of the hypoglossal nerve using an implanted device (Inspire Medical Systems) to activate upper airway dilator muscles during sleep at prescribed therapeutic settings. Matching placebo capsules administered orally at bedtime.
Also known as: HGNS
Atomoxetine 80 mg administered orally at bedtime. Oxybutynin 5 mg administered orally at bedtime. Dose escalation with half-dose for initial 3 nights followed by full dose. HGNS device off
Also known as: AtoOxy
Matching placebo capsules administered orally at bedtime. HGNS device off
Also known as: Placebo
Apnea-Hypopnea Index
Apnea-hypopnea index (AHI), defined as the number of apneas and hypopneas per hour of sleep, measured by overnight polysomnography at the end of each treatment period. Quantitative outcome variable: percent change (symmetrized) from baseline.
Time frame: 2 Weeks
Hypoxic Burden
Hypoxic burden, defined as the area under the oxygen desaturation curve associated with respiratory events multiplied by event frequency, measured during overnight polysomnography. Quantitative outcome variable: percent change (symmetrized) from baseline.
Time frame: 2 Weeks
Visual Analog Scale for Sleep Quality
Self-reported sleep quality measured using a visual analog scale. Quantitative outcome variable: absolute change from baseline. Range: 0-10 (higher values indicate greater sleep quality).
Time frame: 2 Weeks
Epworth Sleepiness Scale (ESS)
Daytime sleepiness assessed using the Epworth Sleepiness Scale (range 0-24, higher scores indicate greater sleepiness). Quantitative outcome variable: absolute change from baseline.
Time frame: 2 Weeks
Visual Analog Scale for Treatment Satisfaction
Self-reported treatment satisfaction measured using a visual analog scale. Quantitative outcome variable: absolute value on treatment. Range: 0-10 (higher values indicate greater treatment satisfaction).
Time frame: 2 Weeks
Sleep Apnea Quality of Life Index (SAQLI)
Disease-specific quality of life assessed using the Sleep Apnea Quality of Life Index. Quantitative outcome variable: absolute change from baseline. Range: 1-7 (higher values indicate greater sleep apnea-related quality of life).
Time frame: 2 Weeks
PROMIS Sleep-Related Impairment
Patient-reported outcomes assessing sleep-related impairment: Quantitative outcome variable: absolute change from baseline. Range: 0-100 (mean 50, SD 10; higher T-scores indicate greater impairment).
Time frame: 2 Weeks
PROMIS Fatigue
Patient-reported outcomes assessing fatigue: Quantitative outcome variable: absolute change from baseline. Range: 0-100 (mean 50, SD 10; higher T-scores indicate greater fatigue).
Time frame: 2 Weeks
PROMIS Sleep Disturbance
Patient-reported outcomes assessing sleep disturbance: Quantitative outcome variable: absolute change from baseline. Range: 0-100 (mean 50, SD 10; higher T-scores indicate greater sleep disturbance).
Time frame: 2 Weeks
Plan to share: Undecided
Started Sep 2026 (actual). Primary completion is estimated for Sep 2028, 24 months after the start.
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