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| ID | Type | Description | Link |
|---|---|---|---|
| UM1HL112856 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Northwestern University | OTHER |
| University of Chicago | OTHER |
| Hektoen Institute for Medical Research | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) |
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This is a proof of concept study to determine the safety and efficacy of dronabinol for the treatment of obstructive sleep apnea syndrome (OSA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sugar Pill | Placebo Comparator | Placebo, once per day (QD) by mouth, 60 minutes before bedtime for 6 weeks after 1-week run-in |
|
| 2.5 mg/day | Experimental | Dronabinol, 2.5 mg QD by mouth, 60 minutes before bedtime for 6 weeks after 1-week placebo run-in |
|
| 10 mg/day | Experimental | Dronabinol, 10 mg QD by mouth, 60 minutes before bedtime for 4 weeks after 1-week placebo run-in and 2-week dose escalation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dronabinol | Drug |
| ||
| Placebo (for Dronabinol) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Apnea/Hypopnea Index (AHI) | Change in AHI derived as: AHI (end of treatment) minus AHI (pre-treatment) | Baseline and Week 6 |
| Change in Epworth Sleepiness Scale (ESS) | Change in ESS derived as: ESS (end of treatment) minus ESS (pre-treatment). The ESS scale has a range of 0 to 24, with 0 representing the least degree of sleepiness and 24 the greatest degree of sleepiness. There are no subscales. | Baseline and Week 6 |
| Change in Sleep Latency: Maintenance of Wakefulness Test (MWT) | Change in MWT derived as: MWT (end of treatment) minus MWT (pre-treatment). The Maintenance of Wakefulness Test measures a person's ability to stay awake in a quiet, dark and nonstimulating room for a period of time. | Baseline and Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability by Treatment Satisfaction Questionnaire for Medications (TSQM) Overall Score. | The TSQM measures a person's satisfaction with treatment based on a 7-point scale ranging from "Extremely Dissatisfied" to "Extremely Satisfied" in response to the question, "Taking all things into account, how satisfied or dissatisfied are you with this medication?". | Week 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David W Carley, PhD | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States | ||
| University of Illinois at Chicago |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29121334 | Derived | Carley DW, Prasad B, Reid KJ, Malkani R, Attarian H, Abbott SM, Vern B, Xie H, Yuan C, Zee PC. Pharmacotherapy of Apnea by Cannabimimetic Enhancement, the PACE Clinical Trial: Effects of Dronabinol in Obstructive Sleep Apnea. Sleep. 2018 Jan 1;41(1):zsx184. doi: 10.1093/sleep/zsx184. |
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Participants were recruited from physician referrals at two academic medical centers as well as from the community based upon print and radio advertising between January 2013 and May 2016. The first participant was enrolled in February 2013 and the last participant was enrolled in April 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sugar Pill | Placebo, once per day (QD) by mouth, 60 minutes before bedtime for 6 weeks after 1-week run-in Placebo (for Dronabinol) |
| FG001 | 2.5 mg/Day | Dronabinol, 2.5 mg QD by mouth, 60 minutes before bedtime for 6 weeks after 1-week placebo run-in Dronabinol |
| FG002 | 10 mg/Day | Dronabinol, 10 mg QD by mouth, 60 minutes before bedtime for 4 weeks after 1-week placebo run-in and 2-week dose escalation Dronabinol |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline analysis population includes all participants who were randomized to treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sugar Pill | Placebo, once per day (QD) by mouth, 60 minutes before bedtime for 6 weeks after 1-week run-in Placebo (for Dronabinol) |
| BG001 | 2.5 mg/Day | Dronabinol, 2.5 mg QD by mouth, 60 minutes before bedtime for 6 weeks after 1-week placebo run-in Dronabinol |
| 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 Apnea/Hypopnea Index (AHI) | Change in AHI derived as: AHI (end of treatment) minus AHI (pre-treatment) | Analysis performed including all participants who completed the full 6-weeks of treatment. | Posted | Mean | Standard Deviation | events/hour | Baseline and Week 6 |
|
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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 | Sugar Pill | Placebo, once per day (QD) by mouth, 60 minutes before bedtime for 6 weeks after 1-week run-in Placebo (for Dronabinol) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cycling injury | Injury, poisoning and procedural complications | Struck by vehicle while riding a bicycle |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sleepy | Nervous system disorders | Increased sleepiness, tiredness or drowsiness |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David W. Carley, PhD | University of Illinois at Chicago | 312-996-3827 | dwcarley@uic.edu |
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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 |
|---|---|
| D013759 | Dronabinol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| NIH |
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| Drug |
|
| Adverse Events (AEs) | AEs will be evaluated and tracked throughout subject participation (up to 8 weeks) | Up to 8 weeks |
| Change in Desaturation Time (DT) | Change in DT (total minutes with arterial oxygen saturation below 85% during 8-hour polysomnography) derived as: DT (end of treatment) minus DT (pre-treatment) | 6 weeks |
| Chicago |
| Illinois |
| 60612 |
| United States |
| Lost to Follow-up |
|
| Physician Decision |
|
| BG002 | 10 mg/Day | Dronabinol, 10 mg QD by mouth, 60 minutes before bedtime for 4 weeks after 1-week placebo run-in and 2-week dose escalation Dronabinol |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Apnea/Hypopnea Index | Mean | Standard Deviation | events/hour |
|
| Minimum Arterial Oxygen Saturation | Mean | Standard Deviation | % |
|
| Sleep Efficiency | Sleep Efficiency is calculated as the total time spent asleep divided by the total amount of time spent in bed, multiplied by 100. | Mean | Standard Deviation | % |
|
| OG002 |
| 10 mg/Day |
Dronabinol, 10 mg QD by mouth, 60 minutes before bedtime for 4 weeks after 1-week placebo run-in and 2-week dose escalation Dronabinol |
|
|
| Primary | Change in Epworth Sleepiness Scale (ESS) | Change in ESS derived as: ESS (end of treatment) minus ESS (pre-treatment). The ESS scale has a range of 0 to 24, with 0 representing the least degree of sleepiness and 24 the greatest degree of sleepiness. There are no subscales. | Data are missing for 2 participants randomized to receive Placebo treatment; due to technical error in not completing this instrument. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 6 |
|
|
|
| Primary | Change in Sleep Latency: Maintenance of Wakefulness Test (MWT) | Change in MWT derived as: MWT (end of treatment) minus MWT (pre-treatment). The Maintenance of Wakefulness Test measures a person's ability to stay awake in a quiet, dark and nonstimulating room for a period of time. | Posted | Mean | Standard Deviation | minutes | Baseline and Week 6 |
|
|
|
| Secondary | Tolerability by Treatment Satisfaction Questionnaire for Medications (TSQM) Overall Score. | The TSQM measures a person's satisfaction with treatment based on a 7-point scale ranging from "Extremely Dissatisfied" to "Extremely Satisfied" in response to the question, "Taking all things into account, how satisfied or dissatisfied are you with this medication?". | Data are missing for one participant randomized to receive Placebo treatment due to technical error in not collecting the instrument. | Posted | Count of Participants | Participants | Week 6 |
|
|
|
| Secondary | Adverse Events (AEs) | AEs will be evaluated and tracked throughout subject participation (up to 8 weeks) | Posted | Mean | Standard Deviation | Number of adverse events per participant | Up to 8 weeks |
|
|
|
| Secondary | Change in Desaturation Time (DT) | Change in DT (total minutes with arterial oxygen saturation below 85% during 8-hour polysomnography) derived as: DT (end of treatment) minus DT (pre-treatment) | Posted | Mean | Standard Deviation | minutes | 6 weeks |
|
|
|
| 1 |
| 26 |
| 9 |
| 26 |
| EG001 | 2.5 mg/Day | Dronabinol, 2.5 mg QD by mouth, 60 minutes before bedtime for 6 weeks after 1-week placebo run-in Dronabinol | 1 | 22 | 13 | 22 |
| EG002 | 10 mg/Day | Dronabinol, 10 mg QD by mouth, 60 minutes before bedtime for 4 weeks after 1-week placebo run-in and 2-week dose escalation Dronabinol | 0 | 27 | 26 | 27 |
| Diarrhea | Gastrointestinal disorders |
|
| Diarrhea | Gastrointestinal disorders |
|
| Headache | Nervous system disorders |
|
| Nausea | Gastrointestinal disorders | Nausea or vomiting |
|
| Dizziness | Nervous system disorders | Dizziness or lightheadedness |
|
| Dry mouth | Gastrointestinal disorders |
|
| Muscle aches | Musculoskeletal and connective tissue disorders |
|
| Euphoria | Nervous system disorders | Euphoria or feeling "high" |
|
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| Dissatisfied |
|
| Somewhat Satisfied |
|
| Satisfied |
|
| Very Satisfied |
|
| Extremely Satisfied |
|