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This is a sponsored proof of concept study with the purpose to examine the safety, tolerability and feasibility of THX-110 (Dronabinol (synthetic Δ9-THC) and PEA) for the treatment of adults with Obstructive Sleep Apnea.
This is a 30-day sponsor-initiated, open-label trial of the therapeutic treatment THX-110 (a combination of Dronabinol and PEA) in 30 adults with Obstructive Sleep Apnea (OSA). Participants will receive THX-110 for the duration of the trial. The goal for this pilot study is to provide initial safety, feasibility and tolerability data on THX-110 in an OSA population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| THX-110 | Experimental | All participants will be titrated up on THX-110 (Dronabinol) dose during the first week of the trial (2.5mg Dronabinol for 3 days, 5mg Dronabinol for 3 days to 7.5mg Dronabinol for 3 days and finally increasing to 10mg for the remainder of the trial). Dronabinol will only be increased if the subject is tolerating the previous dose of Dronabinol and the Dronabinol may be reduced based on patient side-effects. Participants will be receiving 800mg PEA concomitantly. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| THX-110 | Drug | Participants will receive THX-110 in the following regimen: Dronabinol will be slowly titrated in the first 10 days of the study and PEA will be given in a constant dose of 800mg per day for the entire duration of the study. Patients will be followed for a total of 30 days. |
| Measure | Description | Time Frame |
|---|---|---|
| A Significant Change in AHI Index | A significant change in AHI index, which assesses the quality of sleep before and after the treatment. The AHI is the number of apneas or hypopneas recorded during the study per hour of sleep. It is generally expressed as the number of events per hour. Based on the AHI, the severity of OSA is classified as follows: None/Minimal: AHI < 5 per hour Mild: AHI ≥ 5, but < 15 per hour Moderate: AHI ≥ 15, but < 30 per hour Severe: AHI ≥ 30 per hour | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| A Change in Oxygen Desaturation Index (ODI) | A change in oxygen desaturation index (ODI) before and after the treatment ODI is the hourly average number of desaturation episodes, which are defined as at least 4% decrease in saturation from the average saturation in the preceding 120 seconds, and lasting 10 seconds. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety Measurement: Serious Adverse Events (SAEs) | We will measure the incidence of all Serious Adverse Events (SAEs) | 30 days |
| Secondary Safety Measurement: Adverse Events (AEs): Anticipated and Unanticipated (uAEs) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amit S Green, PhD | Contact | +972 3 764 3226 | amitg@assuta.co.il | |
| Lilach Kamer, MD | Contact | +972 3 764 3226 | lilachk@assuta.co.il |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assuta HaShalom | Recruiting | Tel Aviv | 6789140 | Israel |
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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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We will measure the incidence of all Adverse Events (AEs): anticipated and unanticipated (uAEs).
| 30 days |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |