Study of a Combination of Reboxetine\Oxybutynin Versus Placebo in Obstructive Sleep Apnea
- Conditions
- Obstructive Sleep ApneaMedDRA version: 20.0Level: HLTClassification code 10040978Term: Sleep apnoeasSystem Organ Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2019-004917-15-IT
- Lead Sponsor
- ISTITUTO AUXOLOGICO ITALIANO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
1.Participant must be able to understand the nature of the study, must have the opportunity to have any questions answered and must be able to give free informed consent
2.Male or female participants between 18 to 70 years of age
3.AHI = 15 on screening/baseline PSG
4.Participants are eligible for screening/baseline PSG if any of the following:
•Documented prior PSG within 1 year demonstrating AHI of 15 or higher
•Documented Continuous Positive Airway Pressure (CPAP) intolerance or poor compliance (compliance is defined as use of CPAP 4 hours per night for 70% of nights; per participant self-report); or CPAP-naïve.
•Participants who had been using CPAP at least 4 hours nightly for at least 70% of the nights are eligible for further screening and baseline PSG for this study only if CPAP will not have been used for 2 weeks prior to the screening/baseline PSG for this study.
5.Epworth Sleepiness Scale (ESS) score = 4 for participants not using CPAP
6.Previous surgical treatment for OSA is allowed if = 1 year prior to enrollment.
7.BMI between 18.5 and 40.0 kg/m2, inclusive
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
1.History of narcolepsy.
2.Clinically significant craniofacial malformation.
3.Clinically significant cardiac disease or hypertension requiring more than 3 medications for control.
4.Clinically significant neurological disorder, including epilepsy/convulsions
5.History of schizophrenia, schizoaffective disorder or bipolar disorder according to Diagnostic and Statistical Manual of Mental Disorders-V (DSM-V) or International Classification of Disease tenth edition criteria.
6.History of attempted suicide or suicidal ideation within 1 year prior to screening, or current suicidal ideation.
7.Positive history for abuse of drugs or substance use disorder as defined in DSM-V within 12 months prior to Screening Visit.
8.A significant illness or infection requiring medical treatment in the past 30 days.
9.Clinically significant cognitive dysfunction.
10.Untreated narrow angle glaucoma.
11.Women who are pregnant or nursing.
12.History of using oral or nasal devices for the treatment of OSA may enroll as long as the devices are not used during participation in the study.
13.History of using devices to affect participant sleeping position for the treatment of OSA, e.g. to discourage supine sleeping position, may enroll as long as the devices are not used during participation in the study.
14.History of oxygen therapy.
15.Use of medications from the list of disallowed concomitant medications.
16.Treatment with strong cytochrome P450 3A4 (CYP3A4) inhibitors, or monoamine oxidase inhibitors (MAOI) or linezolid within 14 days of the start of treatment, or concomitant with treatment.
17.Use of another investigational agent within 30 days or 5 half-lives, whichever is longer, prior to dosing.
18.Central apnea index > 5/hour on baseline PSG
19.Any condition that in the investigator’s opinion would present an unreasonable risk to the participant, or which would interfere with their participation in the study or confound study interpretation.
20.Participant considered by the investigator, for any reason, an unsuitable candidate to receive Reb/Oxy treatment or unable or unlikely to understand or comply with the dosing schedule or study evaluations.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method