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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
| Stanford University | OTHER |
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The purpose of this study is to test the hypothesis that ingestion of the wake-inhibiting drug suvorexant 30 minutes prior to daytime sleep initiation in individuals working overnight shifts will significantly improve both objective (total sleep time, sleep efficiency, wake after sleep onset) and subjective (sleep quality) measures of daytime sleep.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug | Experimental | 10 mg of suvorexant 30 minutes prior to daytime sleep opportunity |
|
| Placebo | Placebo Comparator | Placebo pill 30 minutes prior to daytime sleep opportunity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suvorexant | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Average Total Sleep Time | Change in average of the total amount of sleep occurring during daytime sleep episodes following night shift work, as compared to baseline | Daytime sleep will be examined from baseline to after 3 weeks |
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Inclusion Criteria:
Aged 20-60 (older individuals excluded due to altered sleep-related circadian signaling)
Males and females
Shift worker
Presence of DSM-5 defined Circadian Rhythm Sleep-Wake Disorder: Shift Work Type
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Palo Alto Health Care System | Palo Alto | California | 94304 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32484552 | Derived | Zeitzer JM, Joyce DS, McBean A, Quevedo YL, Hernandez B, Holty JE. Effect of Suvorexant vs Placebo on Total Daytime Sleep Hours in Shift Workers: A Randomized Clinical Trial. JAMA Netw Open. 2020 Jun 1;3(6):e206614. doi: 10.1001/jamanetworkopen.2020.6614. |
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All relevant data will be provided in the publication
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| ID | Title | Description |
|---|---|---|
| FG000 | Drug | 10+ mg of suvorexant 30 minutes prior to daytime sleep opportunity Suvorexant |
| FG001 | Placebo | Placebo pill 30 minutes prior to daytime sleep opportunity Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Drug | 10 mg of suvorexant 30 minutes prior to daytime sleep opportunity Suvorexant |
| BG001 | Placebo | Placebo pill 30 minutes prior to daytime sleep opportunity Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Change in Average Total Sleep Time | Change in average of the total amount of sleep occurring during daytime sleep episodes following night shift work, as compared to baseline | Posted | Mean | Standard Error | hours/sleep opportunity | Daytime sleep will be examined from baseline to after 3 weeks |
|
5 weeks
Weekly and ad libitum telephone assessment with project coordinator
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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 | Drug | 10+ mg of suvorexant 30 minutes prior to daytime sleep opportunity Suvorexant |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Facial swelling | Musculoskeletal and connective tissue disorders | Systematic Assessment | Participant felt that facial swelling occurred contemporaneously with onset of taking the study medication (placebo). Participant decided to remain in study. Unblinding was not revealed to participant or study team who assessed the data. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jamie Zeitzer | Stanford University | 16504935000 | jzeitzer@stanford.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 | Aug 21, 2015 | Jun 29, 2020 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D020178 | Sleep Disorders, Circadian Rhythm |
| ID | Term |
|---|---|
| D021081 | Chronobiology Disorders |
| D009422 | Nervous System Diseases |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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| ID | Term |
|---|---|
| C551624 | suvorexant |
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| Drug |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Placebo | Placebo pill 30 minutes prior to daytime sleep opportunity Placebo | 0 | 11 | 0 | 11 | 2 | 11 |
|
| Fatigue | Nervous system disorders | Systematic Assessment | Participant felt taking the study medication (placebo) made it more difficult to run in the evening. Participant decided to remain in study. Unblinding was not revealed to participant or study team who assessed the data. |
|
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| D009784 |
| Occupational Diseases |
| D001523 | Mental Disorders |