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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-002360-96 | EudraCT Number |
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This study is conducted to investigate the effects of ACT-541468 on nighttime respiratory function in patients with mild to moderate obstructive sleep apnea
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A: ACT-541468 | Experimental | 50 mg once daily from Day 1 to Day 5 of Period A |
|
| Treatment B: Placebo | Placebo Comparator | Matching placebo once daily from Day 1 to Day 5 of Period B |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACT-541468 | Drug | Film-coated tablet for oral use |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Apnea/hypopnea index (AHI) after multiple-dose administration of ACT-541468 as measured by polysomnography (PSG) | AHI is defined by total number of apnea (pause in respiration ≥ 10 s) plus hypopnea (reduction in airflow or tidal volume from pre-event baseline by 30% for at least 10 s accompanied by a decrease of SaO2 ≥ 4%) events, divided by total sleep time (TST, in min), then multiplied by 60, during TST | After multiple-dose administration (i.e., at Night 5) (duration: 8 hours PSG recording) |
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| Measure | Description | Time Frame |
|---|---|---|
| AHI during TST after single-dose administration | After single-dose (i.e., Night 1) administration (duration: 8 hours PSG recording) | |
| Mean SaO2 during TST | After single-dose (i.e., Night 1) administration (duration: 8 hours PSG recording) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Idorsia Pharmaceuticals Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Sleep Research | Berlin | 10117 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35306405 | Derived | Boof ML, Ufer M, Fietze I, Pepin JL, Guern AS, Lemoine V, Dingemanse J. Assessment of the effect of the dual orexin receptor antagonist daridorexant on various indices of disease severity in patients with mild to moderate obstructive sleep apnea. Sleep Med. 2022 Apr;92:4-11. doi: 10.1016/j.sleep.2021.11.015. Epub 2022 Feb 12. | |
| 33305817 |
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| 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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| ID | Term |
|---|---|
| C000634383 | daridorexant |
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2-way cross-over
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| Placebo |
| Drug |
Film-coated tablet for oral use |
|
| AHI during the awake, non-REM, and REM phases | After single-dose (i.e., Night 1) administration (duration: 8 hours PSG recording) |
| Mean SaO2 during the awake, non-REM, and REM phases | After single-dose (i.e., Night 1) administration (duration: 8 hours PSG recording) |
| Percentage of TST during which SaO2 is < 90%, < 85%, and < 80% | After single-dose (i.e., Night 1) administration (duration: 8 hours PSG recording) |
| Change from baseline to EOP of both periods in subjective next-day performance (morning sleepiness, daytime alertness, and daytime ability to function) as assessed by VAS | After single-dose (i.e., Night 1) and multiple-dose (i.e., Night 5) administration (duration: 2 x 8 hours PSG recording) |
| Objective sleep parameters LPS, WASO, TST, and SEI following single- and multiple-dose administration, as measured by PSG | After single-dose (i.e., Night 1) and multiple-dose (i.e., Night 5) administration (duration: 2 x 8 hours PSG recording) |
| Safety profile including incidence of adverse events (AEs) and serious adverse events (SAEs) | From baseline to EOS (duration: for up to 10 weeks) |
| Boof ML, Dingemanse J, Lederer K, Fietze I, Ufer M. Effect of the new dual orexin receptor antagonist daridorexant on nighttime respiratory function and sleep in patients with mild and moderate obstructive sleep apnea. Sleep. 2021 Jun 11;44(6):zsaa275. doi: 10.1093/sleep/zsaa275. |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |