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COMPLETEDPHASE2

Study of AD128 Versus Placebo in Obstructive Sleep Apnea

Crossover, Double-blind, Phase 2 Study of AD128 Versus Placebo in Obstructive Sleep Apnea

NCT04449133•Istituto Auxologico Italiano

Summary

Obstructive Sleep Apnea (OSA) is the most common and serious of the sleep disorders. Long-term, OSA is associated with increased morbidity and mortality, with a number of adverse cardiovascular, neurocognitive, metabolic, and daytime functioning consequences. No drugs are currently approved for OSA treatment. This is a randomized, double blind, placebo controlled, cross-over, inpatient phase 2 clinical trial to examine the efficacy and the safety of a fixed dose level of AD128 in patients with OSA.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients who are able to understand the nature of the study and to give free informed consent
•AHI ≥ 15 on screening/baseline PSG
•Any of the following conditions should be met:
•1. Documented prior PSG within 1 year demonstrating AHI of 15 or higher
•2. Documented Continuous Positive Airway Pressure (CPAP) intolerance or poor compliance (compliance is defined as self-reported use of CPAP 4 hours per night for 70% of nights) or CPAP-naïve.
•3. Patients who have been using CPAP at least 4 hours nightly for at least 70% of the nights are eligible only if CPAP is not used for 2 weeks prior to the screening/study baseline PSG.
•Epworth Sleepiness Scale (ESS) score ≥ 4 for patients not using CPAP
•Previous surgical treatment for OSA is allowed if ≥ 1 year prior to enrollment.
•BMI between 18.5 and 40.0 kg/m2, inclusive

Exclusion Criteria

•History of narcolepsy.
•Clinically significant craniofacial malformation.
•Clinically significant cardiac disease or hypertension requiring more than 3 medications for control.
•Clinically significant neurological disorder, including epilepsy/convulsions
•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 X edition criteria.
•History of attempted suicide or suicidal ideation within 1 year prior to screening, or current suicidal ideation.
•Positive history for abuse of drugs or substance use disorder as defined in DSM-V within 12 months prior to Screening Visit.
•A significant illness or infection requiring medical treatment in the past 30 days.
•Clinically significant cognitive dysfunction.
•Untreated narrow angle glaucoma.
+10 more criteria

Locations (1)

Istituto Auxologico Italiano,Ospedale San Luca

Milan, Italy

Key Dates

Start Date

July 3, 2020

Primary Completion Date

October 30, 2020

Completion Date

October 31, 2020

Last Updated

September 27, 2021

Enrollment

ACTUAL participants

Conditions

Obstructive Sleep Apnea

Interventions

AD128

DRUG

Placebo

DRUG

OSA Risk Level in Dental Patients and Correlation With Complications After General Anesthesia

NCT06430957

Obstructive Sleep Apnea Risk ManagementPostoperative Complications+2 more

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RECRUITINGNA

Digital-supported Orofacial Myofunctional Therapy in OSA

NCT07292922

Obstructive Sleep Apnea (OSA)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 27, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of AD128 Versus Placebo in Obstructive Sleep Apnea

Inclusion Criteria

Exclusion Criteria

OSA Risk Level in Dental Patients and Correlation With Complications After General Anesthesia

Digital-supported Orofacial Myofunctional Therapy in OSA

Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy

A Cross-sectional Study Examining Adipose Tissue in Obstructive Sleep Apnea

Diaphragm Ultrasound İn Children With OSAS

BodySleep Algorithm for OSA Diagnosis in Children