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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo capsule before bedtime |
|
| LTM1201AZ | Experimental | LTM1201AZ capsule before bedtime |
|
| LTM1201AT | Experimental | LTM1201AT capsule before bedtime |
|
| LTM1201AG | Experimental | LTM1201AG capsule before bedtime |
|
| LTM1201AD | Experimental | LTM1201AD capsule before bedtime |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo oral capsule | Drug | Placebo capsule before bedtime |
| |
| LTM1201AZ |
| Measure | Description | Time Frame |
|---|---|---|
| Apnea hypopnea Index (AHI, average number of events for every hour of sleep) | Based on previous studies the investigators anticipate that active comparators will reduce AHI more effectively in subjects with moderate sleep apnea and low-to-moderate collapsibility (Vpassive >50% of eupneic values). Higher AHI indicates more severe OSA, usually ranging between 10 to 110 events/hour. | 3 nights (treatment duration) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 15, 2024 | Nov 6, 2024 | 5 | ||
| Mar 23, 2026 |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| Drug |
LTM1201AZ oral capsule before sleep |
|
| LTM1201AT | Drug | LTM1201AT oral capsule before sleep |
|
| LTM1201AG | Drug | LTM1201AG oral capsule before sleep |
|
| LTM1201AD | Drug | LTM1201AD oral capsule before sleep |
|
| Mar 24, 2026 |
| 6 |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |