Status:
COMPLETED
Effect of AD128 to Treat Obstructive Sleep Apnea
Lead Sponsor:
Raphael Heinzer
Collaborating Sponsors:
Apnimed
Conditions:
Sleep Apnea, Obstructive
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
This study evaluates the combination of two drugs (AD128), to treat obstructive sleep apnea (OSA) severity. After a baseline evaluation and during 7 days, half of the participants will randomly receiv...
Eligibility Criteria
Inclusion
- Adults (\>18 years and ≤ 65 years)
- New or previous diagnosis of OSA with an AHI \> 15/h on a polygraphic or polysomnographic recording (Participants already treated with continuous positive airway pressure (CPAP) or mandibular advancement device can be included but a 7-days wash-out period is required before the beginning of the protocol and CPAP usage will not be possible during the whole protocol duration),
- Informed Consent as documented by signature (Appendix Informed Consent Form)
Exclusion
- History of seizures,
- History of glaucoma,
- History of benign prostatic hyperplasia, organic miction disorder or urinary retention,
- Gastrointestinal disease (e.g. stenosis, occlusion, ulcerative colitis, toxic megacolon, hiatal hernia…)
- Cardiac arrhythmia,
- History of bipolar disorder,
- Use of respiratory stimulants or depressants,
- Use of Hypnotics,
- Use of Central nervous system stimulants,
- Use of Monoamine oxidase inhibitors (MAOIs) antidepressant,
- Major depressive disorder,
- Central sleep apnea representing more than 10% of all respiratory events
- Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product,
- Pregnant or breast feeding female participants or participants who intend to become pregnant during the study (However, there is no contraindication to contraception),
- Other clinically significant concomitant disease states (renal failure, hepatic dysfunction, severe cardiovascular or respiratory disease, myasthenia gravis, cerebral sclerosis),
- Known or suspected non-compliance, drug or alcohol abuse,
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
- Participation in another study with investigational drug within the 30 days preceding and during the present study
- Use or morphinic and derivatives which may influence sleep,
- Refusal to be informed in case of incidental findings.
Key Trial Info
Start Date :
October 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 19 2021
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04394143
Start Date
October 20 2020
End Date
July 19 2021
Last Update
August 6 2021
Active Locations (1)
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1
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, 1011