NCT03858751 Pharmacological Activation of HMN for OSA Aim 2
| NCT ID | NCT03858751 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Brigham and Women's Hospital |
| Condition | Obstructive Sleep Apnea |
| Study Type | INTERVENTIONAL |
| Enrollment | 16 participants |
| Start Date | 2019-03-01 |
| Primary Completion | 2022-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 16 participants in total. It began in 2019-03-01 with a primary completion date of 2022-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. OSA patients show a marked reduction in upper airway (UA) dilator muscle activity at sleep onset and this phenomenon leads to increased collapsibility of UA compared to normal subjects. In this protocol the investigators will test the effect of LTM1201AZ, LTM1201AT, LTM1201AD, LTM1201AG administered before sleep on OSA phenotype traits and OSA severity during sleep.
Eligibility 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%
Frequently Asked Questions
Who can join the NCT03858751 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Obstructive Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03858751 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03858751 currently recruiting?
Yes, NCT03858751 is actively recruiting participants. Visit ClinicalTrials.gov or contact Brigham and Women's Hospital to inquire about joining.
Where is the NCT03858751 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT03858751 clinical trial?
NCT03858751 is sponsored by Brigham and Women's Hospital. The trial plans to enroll 16 participants.