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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 DAW1033D 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 30 minutes before sleep |
|
| DAW1033D | Active Comparator | DAW1033D capsule 30 minutes before sleep |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo oral capsule | Drug | Placebo before sleep |
| |
| DAW1033D oral capsule |
| Measure | Description | Time Frame |
|---|---|---|
| Apnea Hypopnea Index (AHI, Events/Hour of Sleep) | Based on previous studies the investigators anticipate that DAW1033D will reduce AHI more effectively in subjects with moderate sleep apnea, and mild to moderate pharyngeal collapsibility. AHI describes the frequency of obstruction of the upper airway during sleep and is commonly used to describe the presence and severity of obstructive sleep apnea. | 1 night |
| Measure | Description | Time Frame |
|---|---|---|
| Collapsibility of the Upper Airway: VPassive | Ventilation when ventilatory drive is relatively low during sleep | 1 night |
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Inclusion Criteria:
- AHI > 15
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sleep Disorders Research Program Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33491327 | Derived | Taranto-Montemurro L, Sands S, Azarbarzin A, Calianese N, Vena D, Hess L, Kim SW, White DP, Wellman A. Impact of cold and flu medication on obstructive sleep apnoea and its underlying traits: A pilot randomized controlled trial. Respirology. 2021 May;26(5):485-492. doi: 10.1111/resp.14009. Epub 2021 Jan 24. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo First, DAW1033D Second | Placebo-matching DAW1033D administered 30 mins before normal sleep time on first study night, then a 1-week non-treatment period, then DAW1033D administered 30 mins before normal sleep time on second study night. |
| FG001 | DAW1033D First, Placebo Second | DAW1033D administered 30 mins before normal sleep time on first study night, then a 1-week non-treatment period, then placebo administered 30 mins before normal sleep time on second study night. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Analyzed Participants | All participants who were randomized, completed both study nights, and were included in the analysis. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Apnea Hypopnea Index (AHI, Events/Hour of Sleep) | Based on previous studies the investigators anticipate that DAW1033D will reduce AHI more effectively in subjects with moderate sleep apnea, and mild to moderate pharyngeal collapsibility. AHI describes the frequency of obstruction of the upper airway during sleep and is commonly used to describe the presence and severity of obstructive sleep apnea. | 1 participant was not analyzed because he dropped out between the 2 intervention arms | Posted | Median | Inter-Quartile Range | events/hour of sleep | 1 night |
|
1 night
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo capsule 30 minutes before sleep Placebo oral capsule: Placebo before sleep |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| insomnia | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Luigi Taranto Montemurro, MD | Brigham and Women's Hospital | 6177326541 | ltarantomontemurro@bwh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 17, 2016 | Jan 22, 2020 | Prot_SAP_000.pdf |
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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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| Drug |
DAW1033D before sleep |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
DAW1033D capsule 30 minutes before sleep
DAW1033D oral capsule: DAW1033D before sleep
|
|
|
| Secondary | Collapsibility of the Upper Airway: VPassive | Ventilation when ventilatory drive is relatively low during sleep | Posted | Median | Inter-Quartile Range | % eupneic ventilation | 1 night |
|
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | DAW1033D | DAW1033D capsule 30 minutes before sleep DAW1033D oral capsule: DAW1033D before sleep | 0 | 10 | 0 | 10 | 1 | 10 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |