Health TrialsbyHealthPanel

A Study Of Synthetic THC And Sleep

ConditionObstructive Sleep Apnea
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age21-70
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

21 - 70 years of age

Biological male or female

AHI between 15 - 50 events/hour

Current or new OSA diagnosis

Disqualifiers

BMI > 35 kg/m2

Diagnosed psychiatric disorders

Hypotension

History of seizures

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dronabinol

    Drug

    10 mg dose of Dronabinol daily for 6 weeks

  • Placebo

    Drug

    10 mg dose of Placebo daily for 6 weeks

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: DronabinolExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of times subjects complete CPAP therapy

CPAP therapy is defined as using the therapeutic device for ≥ 4 hours per night

Time frame
Baseline
2

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).

Time frame
Day 15, Day 29, and Day 42
3

International Physical Activity Questionnaire

International Physical Activity Questionnaire is a 0-10 visual analog scale to assess self-reported sleep quality

Time frame
Baseline and Day 42

Secondary outcomes

1

24-hour blood pressure

Blood pressure will be monitored for 24 hours and reported as mm/Hg

Time frame
Baseline and Day 42
2

Blood Pressure

Blood Pressure will be reported as mm/Hg

Time frame
Baseline, Day 22, and Day 42

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: