Sleep Apnea, ObstructivePhase 2PACENCT01755091
Safety and Efficacy Study of Dronabinol to Treat Obstructive Sleep Apnea
A Phase 2 study testing Dronabinol in people with Sleep Apnea, Obstructive, run by University of Illinois Chicago at 2 sites in United States.
Trial summary
This is a proof of concept study to determine the safety and efficacy of dronabinol for the treatment of obstructive sleep apnea syndrome (OSA). Read more about this study
- Who is it for?
- Ages 21 to 64 years
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- Dronabinol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2013to 31 Dec 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult 21 to 64 years of age;
- 15≤AHI ≤ 50 on screening polysomnogram (PSG)
- ESS score ≥ 7
- Able to understand and complete informed consent and all study assessments and forms, presented in an English-speaking format;
- Women of child-bearing potential (WCBP) must have a negative urine pregnancy test. In addition sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable or implantable hormonal contraceptive; tubal ligation; intra-uterine devices; barrier contraceptive with spermicide; or vasectomized partner).
Who cannot join
- Arterial oxygen saturation < 75% for > 5% of sleep period time on screening PSG;
- Occupation or life situation that may impart risk by study participation (e.g. commercial driver, pilot, police officer, fireman);
- Motor vehicle accident or "near-miss" related to sleepiness (self-report) within 2 years of the first dose of study drug (Day 8);
- Body mass index > 45 kg/m2
- Severe obstructive sleep apnea syndrome (OSAS) that, based on the clinical judgment of the Investigator, precludes delaying positive airway pressure treatment;
- History of shift work or rotating shifts within the month prior to the first dose of study drug (Day 8);
Show all 29Show fewer
- Prior upper airway surgery for snoring or OSAS as an adult (≥ 18 years of age);
- Prior non-invasive treatment for OSAS within 6 months prior to the first dose of study drug (Day 8);
- Major surgery within 6 months prior to the first dose of study drug (Day 8);
- Bariatric surgery within 2 years prior to the first dose of study drug (Day 8). If post-bariatric surgery, weight must be stable ±5% (self-report) for at least 6 months prior to first dose of study drug (Day 8).
- Any form of medically managed weight loss program within 6 months prior to the first dose of study drug (Day 8);
- Significant defect in nasal patency due to anatomical abnormalities or uncontrolled or recurrent episodes of rhinitis;
- Any clinically significant unstable or progressive medical condition;
- Any primary sleep disorder other than OSAS as determined by history, physical examination, or Visit 2 PSG (after 7-day screening run-in period);
- Clinically significant or uncontrolled: chronic obstructive pulmonary disease (COPD), cardiovascular disease, gastrointestinal, respiratory, pancreatic, hepatic, renal, hematologic, endocrine [including insulin-dependent diabetes mellitus (IDDM)], neurological, urogenital, connective tissue, dermatological, thyroid, or other medical disorder;
- Any clinically significant psychiatric disorder;
- History of seizure disorder;
- Treatment with any prescription antidepressant medication within 1 month prior to the first dose of study drug (Day 8);
- Treatment with sedatives, hypnotics or other psychoactive drugs within 30 days prior to the first dose of study drug (Day 8);
- Any complete blood count (CBC) or liver function test (LFT) laboratory value outside the normal range which, in the clinical judgment of the Investigator renders a subject inappropriate for randomization to treatment;
- Pregnancy [as demonstrated by positive urine human chorionic gonadotropin (hCG) test] or lactation;
- Allergic to cannabinoids or sesame oil;
- History of substance abuse (including alcohol abuse or dependence) or laboratory evidence of drug abuse on the Visit 1 drug-screening panel;
- Use of dietary supplements which in the judgment of the Investigator may impact sleep or breathing behaviors;
- Average daily caffeine consumption > 500 mg/day (~5 cups of coffee);
- Average weekly alcohol consumption > 10 units;
- Unwillingness to abstain from caffeine and alcohol on all days when overnight or daytime testing will be performed;
- Participation in any other investigational protocol within the 30 days prior to the first dose of study drug (Day 8);
- Any condition which, in the opinion of the Investigator, places the patient at unacceptable risk if he or she were to participate in the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern University
Chicago, Illinois, 60611
University of Illinois at Chicago
Chicago, Illinois, 60612
About this study
Official title: Cannabimimetic Treatment of Obstructive Sleep Apnea: A Proof of Concept Trial
This is a proof of concept study to determine the safety and efficacy of dronabinol for the treatment of obstructive sleep apnea syndrome (OSA).
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- Dronabinol, Placebo (for Dronabinol)
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DronabinolDrug
Placebo (for Dronabinol)Drug
| Study group | Role | What they receive |
|---|---|---|
| Sugar Pill | Placebo comparator | Placebo, once per day (QD) by mouth, 60 minutes before bedtime for 6 weeks after 1-week run-in Receives: Drug: Placebo (for Dronabinol) |
| 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 Receives: Drug: Dronabinol |
| 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 Receives: Drug: Dronabinol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Apnea/Hypopnea Index (AHI)
Change in AHI derived as: AHI (end of treatment) minus AHI (pre-treatment)
Measured: 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.
Measured: 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.
Measured: Baseline and Week 6
Secondary outcomes (3)
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?".
Measured: Week 6
Adverse Events (AEs)
AEs will be evaluated and tracked throughout subject participation (up to 8 weeks)
Measured: 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)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2012 (estimated)
- Study startFeb 2013
- Primary completionJun 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University, University of Chicago, Hektoen Institute for Medical Research, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, David W. Carley, University of Illinois Chicago
- Investigators
- David W Carley, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01755091
- Sponsor's protocol ID
- 2012-0095
- Other IDs
- UM1HL112856
- Acronym
- PACE
- Status last verified
- Jul 2021
- First submitted
- 18 Dec 2012
- Last updated
- 29 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 29121334
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabimimetic Treatment of Obstructive Sleep Apnea: A Proof of Concept Trial
- ClinicalTrials.gov ID
- NCT01755091
- Acronym / sponsor ID
- PACE / 2012-0095
- Conditions
- Sleep Apnea, Obstructive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- Northwestern University, University of Chicago, Hektoen Institute for Medical Research, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Feb 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 21 Dec 2012 (estimated)
- Results
- Posted 22 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a proof of concept study to determine the safety and efficacy of dronabinol for the treatment of obstructive sleep apnea syndrome (OSA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sugar Pill | Placebo comparator | Drug: Placebo (for Dronabinol)Placebo, once per day (QD) by mouth, 60 minutes before bedtime for 6 weeks after 1-week run-in |
| 2.5 mg/day | Experimental | Drug: DronabinolDronabinol, 2.5 mg QD by mouth, 60 minutes before bedtime for 6 weeks after 1-week placebo run-in |
| 10 mg/day | Experimental | Drug: DronabinolDronabinol, 10 mg QD by mouth, 60 minutes before bedtime for 4 weeks after 1-week placebo run-in and 2-week dose escalation |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adult 21 to 64 years of age;
- 15≤AHI ≤ 50 on screening polysomnogram (PSG)
- ESS score ≥ 7
- Able to understand and complete informed consent and all study assessments and forms, presented in an English-speaking format;
- Women of child-bearing potential (WCBP) must have a negative urine pregnancy test. In addition sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable or implantable hormonal contraceptive; tubal ligation; intra-uterine devices; barrier contraceptive with spermicide; or vasectomized partner).
Key exclusion criteria (29 listed)
- Arterial oxygen saturation < 75% for > 5% of sleep period time on screening PSG;
- Occupation or life situation that may impart risk by study participation (e.g. commercial driver, pilot, police officer, fireman);
- Motor vehicle accident or "near-miss" related to sleepiness (self-report) within 2 years of the first dose of study drug (Day 8);
- Body mass index > 45 kg/m2
- Severe obstructive sleep apnea syndrome (OSAS) that, based on the clinical judgment of the Investigator, precludes delaying positive airway pressure treatment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dronabinol | Drug | 10 mg/day, 2.5 mg/day |
| Placebo (for Dronabinol) | Drug | Sugar Pill |
Primary outcome
Change in Apnea/Hypopnea Index (AHI)
Time frame: Baseline and Week 6
Change in AHI derived as: AHI (end of treatment) minus AHI (pre-treatment)
Change in Epworth Sleepiness Scale (ESS)
Time frame: Baseline and Week 6
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.
Change in Sleep Latency: Maintenance of Wakefulness Test (MWT)
Time frame: Baseline and Week 6
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.
3 secondary outcomes
Tolerability by Treatment Satisfaction Questionnaire for Medications (TSQM) Overall Score.
Time frame: Week 6
Adverse Events (AEs)
Time frame: Up to 8 weeks
Change in Desaturation Time (DT)
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29121334Carley 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.
Related trials for Sleep Apnea, Obstructive
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David W Carley, PhD principal investigator
University of Illinois Chicago
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dronabinol in people with Sleep Apnea, Obstructive, run by University of Illinois Chicago at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Apnea/Hypopnea Index (AHI) (time frame: Baseline and Week 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01755091, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2021.