Obstructive Sleep Apnea
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGTHX-110
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.
Sponsors
SciSparc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* OSA diagnosis; OSA severity AHI: 15-30 * Population aged 20-65 * Gender: Males and Females * BMI \< 30 * OSA patients that cannot tolerate CPAP * OSA patients who use CPAP will not use the device during the entire duration of the study
Exclusion criteria
* Minors * Severity of OSA outside the determined boundaries * Pregnancy * BMI \> 30 * Medical history of narcotic dependency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A Significant Change in AHI Index | 30 days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| A Change in Oxygen Desaturation Index (ODI) | 30 days | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Measurement: Serious Adverse Events (SAEs) | 30 days | We will measure the incidence of all Serious Adverse Events (SAEs) |
| Secondary Safety Measurement: Adverse Events (AEs): Anticipated and Unanticipated (uAEs) | 30 days | We will measure the incidence of all Adverse Events (AEs): anticipated and unanticipated (uAEs). |
Countries
Israel
Contacts
Primary ContactAmit S Green, PhD
Backup ContactLilach Kamer, MD
Outcome results
None listed