Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine if oral dronabinol prior to sleep can improve CPAP adherence and sleep quality in humans. We also seek to determine if combination therapy of CPAP and pre-sleep dronabinol is associated with improved BP regulation. We will also explore BP regulatory mechanisms and whether these are impacted differently between traditional CPAP therapy and combination CPAP/dronabinol.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dronabinol | Experimental | Patients assigned to the Dronabinol arm will be taking the Study drug (Dronabinol) one hour prior to bed each night for 6 weeks. |
|
| Placebo | Placebo Comparator | Patients assigned to the placebo arm will be taking the placebo pill (sugar pill) one hour prior to bed each night for 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dronabinol | Drug | 10 mg dose of Dronabinol daily for 6 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of times subjects complete CPAP therapy | CPAP therapy is defined as using the therapeutic device for ≥ 4 hours per night | Baseline |
| Apnea-hypopnea index (AHI) | Apnea-hypopnea index (AHI) an index used to describe the number of apneas experienced during sleep. It is calculated by (Number of hours of sleep/Number of Apneas or hypopneas). This value will then be graded on a scale from Normal (<5) to Severe (>30). | Day 15, Day 29, and Day 42 |
| International Physical Activity Questionnaire | International Physical Activity Questionnaire is a 0-10 visual analog scale to assess self-reported sleep quality | Baseline and Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| 24-hour blood pressure | Blood pressure will be monitored for 24 hours and reported as mm/Hg | Baseline and Day 42 |
| Blood Pressure | Blood Pressure will be reported as mm/Hg |
Not provided
Inclusion Criteria
Exclusion Criteria
BMI > 35 kg/m2
Diagnosed psychiatric disorders
Hypotension
History of seizures
History of substance abuse or recreational drug use or positive urine drug screen
History of uncontrolled disease including:
Pregnant or breastfeeding
Use of certain antimicrobial, chemotherapeutic, anticoagulant, hypoglycemic, anti-inflammatory, psychotropic, and antihistamine drugs
Prescribed CYP2C9 and/or CYP3A4 inhibitors
Severe OSA that in the investigator's judgment should only begin CPAP treatment
Prior upper airway surgery for snoring or OSA as an adult
Significant defect in nasal patency due to anatomical abnormality or uncontrolled rhinitis
Bariatric surgery within 2 years
Medically managed weight-loss program within 6 months
Noninvasive treatment for OSA within 1 month (self-report)
History of shift work or rotating shifts within 1 month
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chieko Allgauer | Contact | 507-422-3499 | allgauer.chieko@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Virend Somers, M.D., Ph.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D013759 | Dronabinol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
10 mg dose of Placebo daily for 6 weeks |
|
| Baseline, Day 22, and Day 42 |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |