Boston, MANCT07577661Now EnrollingIRB Ready

Obstructive Sleep Apnea Clinical Trial in Boston, MA

Access cutting-edge obstructive sleep apnea treatment through this phase 1/2 clinical trial at a research site in Boston. Study-provided care at no cost to qualified participants.

Sponsored by Brigham and Women's Hospital

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Expert Care in Boston

Access obstructive sleep apnea specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related obstructive sleep apnea treatment provided free

Apply for This Boston Location

Check if you qualify for this obstructive sleep apnea clinical trial in Boston, MA

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Why Participate?

  • No-Cost Study Care

  • Local to Boston

    Convenient for MA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Boston site if eligible
  4. 4Begin participation

About This Obstructive Sleep Apnea Study in Boston

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.

Sponsor: Brigham and Women's Hospital

Who Can Participate

Inclusion Criteria

for Enrolment:
Ages 18 - 79 years
Diagnosed OSA
Implantation of a hypoglossal nerve stimulation device (HGNS, Inspire Medical) or scheduled for implantation (implantation required for randomization)
Willingness to withhold HGNS while testing therapies (up to 6 weeks with HGNS off \[with/without pharmacotherapy\] to assess benefits of HGNS therapy).

Exclusion Criteria

Any uncontrolled medical condition
Current use of the medications under investigation.
Issues relating to short-term withdrawal of HGNS therapy
Excluded: Occupational driving (truck drivers, fork-lift operation, taxi/uber drivers)
Excluded: History of traffic accidents attributable to sleepiness or fatigue (\<2 years).
Use of SNRIs/SSRIs or anticholinergic medications during the study.
Conditions likely to affect obstructive sleep apnea physiology: neuromuscular disease or other major neurological disorder, heart failure (also below), or any other unstable major medical condition.
Respiratory disorders other than sleep disordered breathing: chronic hypoventilation/hypoxemia (awake SaO2 \< 92% by oximetry) due to chronic obstructive pulmonary disease or other respiratory conditions.
Other sleep disorders: narcolepsy, parasomnias. Insomnia
Contraindications for atomoxetine and oxybutynin, including:
hypersensitivity to atomoxetine or oxybutynin (angioedema or urticaria)
pheochromocytoma
use of monoamine oxidase inhibitors
diagnosed benign prostatic hypertrophy, urinary retention
suspected benign prostatic hypertrophy / urinary retention based on a positive answer to either of the following questions:
"During the last month, when urinating, have you had the sensation of not emptying your bladder completely more often than 1 out of 5 times?"
"During the last month, have you had a weak urinary stream more often than 1 out of 5 times?
known untreated narrow angle glaucoma
known bipolar disorder, mania, psychosis
known history of major depressive disorder (age\<24).
known history of attempted suicide or suicidal ideation within one year prior to screening
known clinically significant constipation, gastric retention
known pre-existing seizure disorders
known clinically-significant kidney disorders (eGFR\<60 ml/min/1.73m2)
known clinically-significant liver disorders
known clinically-significant cardiovascular conditions
moderate-to-severe hypertension (SBP\>160 mmHg or DBP\>100 mmHg measured at baseline; average of evening and morning measures)
known cardiomyopathy (LVEF\<50%) or heart failure
known advanced atherosclerosis
recent cerebrovascular events (within 2 years)
recent history of cardiac arrhythmias e.g., atrial fibrillation, QT prolongation (within 2 years)
other serious cardiac conditions that would raise the consequences of an increase in blood pressure or heart rate
myasthenia gravis
pregnancy/breast-feeding

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 Boston?

Yes, this clinical trial (NCT07577661) has an active research site in Boston, MA 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 Boston, MA

If you're searching for obstructive sleep apnea treatment options in Boston, MA, this clinical trial (NCT07577661) 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 Boston research site is actively enrolling participants for this phase 1/2 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.

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