Testing new medications for obstructive sleep apnea
Pharmacological Activation of Hypoglossal Motor Nucleus for Obstructive Sleep Apnea Aim 2
PHASE1; PHASE2 · Brigham and Women's Hospital · NCT03858751
This study is testing four new medications to see if they can help people with obstructive sleep apnea breathe better during sleep.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Brigham and Women's Hospital (other) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT03858751 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of four different medications (LTM1201AZ, LTM1201AT, LTM1201AD, LTM1201AG) on patients with obstructive sleep apnea (OSA). The study aims to determine how these medications influence upper airway muscle activity and the severity of OSA during sleep. Participants will receive either the medications or a placebo before sleep to assess their impact on OSA traits. The trial is designed to provide insights into potential new treatments for this common condition.
Who should consider this trial
Good fit: Ideal candidates are adults with obstructive sleep apnea characterized by an apnea-hypopnea index (AHI) greater than 10 events per hour during NREM supine sleep.
Not a fit: Patients with severe obstructive sleep apnea, underlying cardiac disease, or those taking certain psychiatric medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new pharmacological treatments for obstructive sleep apnea, improving patient outcomes and quality of life.
How similar studies have performed: While there have been various approaches to treating obstructive sleep apnea, the specific pharmacological activation of upper airway muscles in this manner is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * AHI \> 10 events/h during NREM supine sleep Exclusion Criteria: * Any medical condition other than well controlled hypertension and mild diabetes. * Any medication known to influence breathing, sleep/arousal, or muscle physiology. * Claustrophobia. * Inability to sleep supine. * Allergy to any of the medications tested in the protocol. * History of kidney stones, hypercalcemia, primary hyperparathyroidism, sarcoidosis, hypervitaminosis D. * Individuals with underlying cardiac disease, such as arrhythmias. * Individuals taking psychiatric medications, such as an MAO-I, SSRI or SNRI, or any of the studied medications for medical care. * For women: Pregnancy. * Pulmonary hypertension * Severe OSA with a mean SaO2 lower than 88%
Where this trial is running
Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts, United States (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obstructive Sleep Apnea