- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04394143
Effect of AD128 to Treat Obstructive Sleep Apnea
Effect of AD128 on Obstructive Sleep Apnea Severity: a Randomized, Placebo-controlled, Double-blind, Cross-over Study
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
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Lausanne, Switzerland, 1011
- Centre hospitalier universitaire vaudois
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: AD128
The study specific intervention includes per oral administration of two capsules of AD128, once daily, just before lights out, for 7 days.
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Oral administration of two capsules before sleep for 7 days.
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Placebo Comparator: placebo
Two placebo capsules (Mannitol) will be administered for the control intervention once daily, just before light outs, for one week.
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Oral administration of two capsules before sleep for 7 days.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Apnea-hypopnea index (AHI)
Time Frame: Day 7 and 21
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Change from baseline AHI (events/h) measured via polysomnography between the week of investigational treatment (AD128) and the week of placebo treatment.
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Day 7 and 21
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oxygen desaturation index (ODI)
Time Frame: Day 7 and 21
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Change from baseline ODI (events/h) measured via polysomnography between the week of investigational treatment (AD128) and the week of placebo treatment.
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Day 7 and 21
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Oxygen desaturation index (ODI) in REM and NREM
Time Frame: Day 7 and 21
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Change from baseline ODI (events/h) measured via polysomnography during rapid eye movement (REM) and non rapid eye movement (NREM) sleep between the week of investigational treatment (AD128) and the week of placebo treatment.
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Day 7 and 21
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Hypoxic load
Time Frame: Day 7 and 21
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Change from baseline hypoxic load (area under the curve of 3% oxygen desaturation related to apnea-hypopnea events) measured via polysomnography between the week of investigational treatment (AD128) and the week of placebo treatment.
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Day 7 and 21
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Hypoxic load in REM and NREM
Time Frame: Day 7 and 21
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Change from baseline hypoxic load (area under the curve of 3% oxygen desaturation related to apnea-hypopnea events) measured via polysomnography during rapid eye movement (REM) and non rapid eye movement (NREM) sleep between the week of investigational treatment (AD128) and the week of placebo treatment.
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Day 7 and 21
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Arousal index
Time Frame: Day 7 and 21
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Change from baseline arousal index (events/h) measured via polysomnography between the week of investigational treatment (AD128) and the week of placebo treatment.
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Day 7 and 21
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Arousal index in REM and NREM
Time Frame: Day 7 and 21
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Change from baseline arousal index (events/h) measured via polysomnography during rapid eye movement (REM) and non rapid eye movement (NREM) sleep between the week of investigational treatment (AD128) and the week of placebo treatment.
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Day 7 and 21
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Pulse wave amplitude (PWA) drops
Time Frame: Day 7 and 21
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Change from baseline PWA drops (events/h) measured via polysomnography between the week of investigational treatment (AD128) and the week of placebo treatment.
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Day 7 and 21
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Pulse wave amplitude (PWA) drops in REM and NREM
Time Frame: Day 7 and 21
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Change from baseline PWA drops (events/h) measured via polysomnography during rapid eye movement (REM) and non rapid eye movement (NREM) sleep between the week of investigational treatment (AD128) and the week of placebo treatment.
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Day 7 and 21
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Apnea-hypopnea index (AHI) in REM and NREM
Time Frame: Day 7 and 21
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Change from baseline AHI (events/h) measured via polysomnography during rapid eye movement (REM) and non rapid eye movement (NREM) sleep between the week of investigational treatment (AD128) and the week of placebo treatment.
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Day 7 and 21
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Percentage of REM sleep
Time Frame: Day 7 and 21
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Change from baseline REM sleep (% of total sleep time) measured via polysomnography between the week of investigational treatment (AD128) and the week of placebo treatment.
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Day 7 and 21
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Percentage of N1
Time Frame: Day 7 and 21
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Change from baseline sleep stage 1 (N1: % of total sleep time) measured via polysomnography between the week of investigational treatment (AD128) and the week of placebo treatment.
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Day 7 and 21
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Percentage of N2
Time Frame: Day 7 and 21
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Change from baseline sleep stage 2 (N2: % of total sleep time) measured via polysomnography between the week of investigational treatment (AD128) and the week of placebo treatment.
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Day 7 and 21
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Percentage of N3
Time Frame: Day 7 and 21
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Change from baseline sleep stage 3 (N3: % of total sleep time) measured via polysomnography between the week of investigational treatment (AD128) and the week of placebo treatment.
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Day 7 and 21
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Percentage of alpha wave
Time Frame: Day 7 and 21
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Change from baseline alpha wave frequency (8-13 Hz - % of total sleep time) measured via polysomnography in REM and NREM between the week of investigational treatment (AD128) and the week of placebo treatment.
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Day 7 and 21
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Percentage of beta wave
Time Frame: Day 7 and 21
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Change from baseline beta wave frequency (13-30 Hz - % of total sleep time) measured via polysomnography in REM and NREM between the week of investigational treatment (AD-128) and the week of placebo treatment.
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Day 7 and 21
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Percentage of gamma wave
Time Frame: Day 7 and 21
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Change from baseline gamma wave frequency (30-100 Hz - % of total sleep time) measured via polysomnography in REM and NREM between the week of investigational treatment (AD128) and the week of placebo treatment.
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Day 7 and 21
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Percentage of theta wave
Time Frame: Day 7 and 21
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Change from baseline theta wave frequency (4-8 Hz - % of total sleep time) measured via polysomnography in REM and NREM between the week of investigational treatment (AD128) and the week of placebo treatment.
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Day 7 and 21
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Percentage of delta wave
Time Frame: Day 7 and 21
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Change from baseline delta wave frequency (1-4 Hz - % of total sleep time) measured via polysomnography in REM and NREM between the week of investigational treatment (AD128) and the week of placebo treatment.
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Day 7 and 21
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Reaction time PVT
Time Frame: Day 7 and 21
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Change from baseline reaction time (in ms) during Psychomotor Vigilance Task (PVT).
During 10 min, subjects were instructed to press a button as quickly as possible when a red millisecond-counter appeared on a small screen (PVT-192, Ambulatory Monitoring Inc.).
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Day 7 and 21
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Lapse PVT
Time Frame: Day 7 and 21
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Change from baseline lapse time (in ms) during Psychomotor Vigilance Task (PVT) and defined as reaction time > 500 ms).
During 10 min, subjects were instructed to press a button as quickly as possible when a red millisecond-counter appeared on a small screen (PVT-192, Ambulatory Monitoring Inc.).
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Day 7 and 21
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Chronic Excessive daytime sleepiness (EDS)
Time Frame: Day 7 and 21
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Change from baseline Epworth Sleepiness Scale (ESS) score between the week of investigational treatment (AD128) and the week of placebo treatment. The ESS is a 8-item questionnaire. ESS score can range from 0 to 24. The higher the ESS score, the higher daytime sleepiness. |
Day 7 and 21
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Acute Excessive daytime sleepiness (EDS)
Time Frame: Day 7 and 21
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Change from baseline Stanford Sleepiness Scale (SSS) score between the week of investigational treatment (AD128) and the week of placebo treatment. Consisting of only one item, the scale requires respondents to select one of seven statements best representing their level of perceived sleepiness. The scale range from 1 to 7. Higher score indicates greater sleepiness. |
Day 7 and 21
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Sleep quality
Time Frame: Day 7 and 21
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Change from baseline visual analogic scale (VAS) sleep quality score between the week of investigational treatment (AD128) and the week of placebo treatment.
Score ranges from 0 to 10. Higher score indicates better sleep quality.
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Day 7 and 21
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Fatigue
Time Frame: Day 7 and 21
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Change from baseline Pichot scale score between the week of investigational treatment (AD128) and the week of placebo treatment. The Pichot scale is a 8-items auto-questionnaire to assess excessive fatigue. Score varies between 0 and 32, a score > 22 indicates excessive fatigue. |
Day 7 and 21
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Systolic and diastolic blood pressure
Time Frame: Day 7 and 21
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Change from baseline office systolic and diastolic blood pressure (BP in mm Hg) between the week of investigational treatment (AD128) and the week of placebo treatment. The Pichot scale is a 8-items auto-questionnaire to assess excessive fatigue. Score varies between 0 and 32, a score > 22 indicates excessive fatigue. |
Day 7 and 21
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Raphael Heinzer, MD, University Hospital of Lausanne (CHUV)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Respiratory Tract Diseases
- Respiration Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Signs and Symptoms, Respiratory
- Sleep Apnea Syndromes
- Sleep Apnea, Obstructive
- Apnea
- Physiological Effects of Drugs
- Natriuretic Agents
- Diuretics, Osmotic
- Diuretics
- Mannitol
Other Study ID Numbers
- 2020-00315
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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