Pharmacological Activation of HMN for OSA
Completed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Obstructive Sleep Apnea
In brief
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 LTM1201L, LTM1201LN, LTM1201LB, LTM1201LD administered before sleep on OSA phenotype traits and OSA severity during sleep.
Key facts
- Study ID
- NCT03640052
- Run by
- Brigham and Women's Hospital
- People needed
- 6
- Starts
- 2018-10-30
- Expected to finish
- 2019-12-31
- Last updated by the study team
- 2020-02-24
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- AHI > 10 events/h during NREM supine sleep
You may not qualify if…
- 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 it is running
- Brigham and Women's Hospital — Boston, Massachusetts, United States
- Sleep Disorders Research Program Brigham and Women's Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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