Phase 2
Completed N=6
Pharmacological Activation of HMN for OSA
Source: ClinicalTrials.gov NCT03640052 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcomePrimary: Apnea Hypopnea Index (AHI, Average Number of Events for Every Hour of Sleep) — 20.8; 24.4; 18.8; 14 events/hour of sleep — p=>0.5
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 LTM1201L, LTM1201LN, LTM1201LB, LTM1201LD administered before sleep on OSA phenotype traits and OSA severity during sleep.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Apnea Hypopnea Index (AHI, Average Number of Events for Every Hour of Sleep) |
20.8; 24.4; 18.8; 14; 9.1 | >0.5 |
| SECONDARY Collapsibility of the Upper Airway: VActive (L/Min) |
2.657; 3.856; 3.822; 6.008; 3.091 | 0.12 |
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%
Data sourced from ClinicalTrials.gov (NCT03640052). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.