Effect of AD128 to Treat Obstructive Sleep Apnea

NCT04394143 | Completed Phase 2 DMC

• 1 other identifier: 2020-00315
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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 receive this drug combination (AD128) and the other will receive a placebo, i.e. a drug without pharmaceutical effect. Neither the participants, nor the investigators will know in which arm participants are until the end of the study. After one week of trial, an evaluation will be perform and will be follow by one week without any treatment. During the third and last week of trial, there will be a crossover of the groups, i.e. the participants of the first group who took the two drugs (AD128) during the first week will take a placebo and those who took the placebo will take the drugs combination.

Conditions

Sleep Apnea, Obstructive

Keywords

obstructive sleep apnea; pharmacologic treatment; sleepiness; vigilance

Outcome Measures

Primary Outcomes (1)

• Apnea-hypopnea index (AHI)

  Change from baseline AHI (events/h) measured via polysomnography between the week of investigational treatment (AD128) and the week of placebo treatment.

  Day 7 and 21

Secondary Outcomes (25)

• Oxygen desaturation index (ODI)

  Day 7 and 21

• Oxygen desaturation index (ODI) in REM and NREM

  Day 7 and 21

• Hypoxic load

  Day 7 and 21

• Hypoxic load in REM and NREM

  Day 7 and 21

• Arousal index

  Day 7 and 21

Study Arms (2)

AD128

EXPERIMENTAL

The study specific intervention includes per oral administration of two capsules of AD128, once daily, just before lights out, for 7 days.

Drug: AD128

placebo

PLACEBO COMPARATOR

Two placebo capsules (Mannitol) will be administered for the control intervention once daily, just before light outs, for one week.

Drug: Mannitol

Interventions

AD128 DRUG

Oral administration of two capsules before sleep for 7 days.

AD128

Mannitol DRUG

Oral administration of two capsules before sleep for 7 days.

Also known as: Placebo

placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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),

Sponsors & Collaborators

• Raphael Heinzer: lead
• Apnimed: collaborator

Study Sites (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, 1011, Switzerland

Location

Related Publications (1)

• Berger M, Solelhac G, Marchi NA, Dussez R, Bradley B, Lecciso G, Heiniger G, Bayon V, Van Den Broecke S, Haba-Rubio J, Siclari F, Heinzer R. Effect of oxybutynin and reboxetine on obstructive sleep apnea: a randomized, placebo-controlled, double-blind, crossover trial. Sleep. 2023 Jul 11;46(7):zsad051. doi: 10.1093/sleep/zsad051.

  PMID: 36861433 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleepiness

Interventions

Mannitol

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Study Officials

• Raphael Heinzer, MD

  University Hospital of Lausanne (CHUV)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Evaluators, investigators and patients will be blinded to treatment allocation. Treatments will be prepared and conditioned by the Pharmacy Service of the University Hospital of Lausanne according to a randomisation list performed by an independent statistician. The Pharmacy service is completely independent from the Center for Investigation and Research in Sleep (CIRS). Unblinding will be performed after statistical analysis is completed by a statistician blinded to treatment assignment.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Raphael Heinzer

Model Details: This is a randomized, placebo-controlled, double-blind crossover study

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: May 19, 2020
• Study Start: October 20, 2020
• Primary Completion: July 19, 2021
• Study Completion: July 19, 2021
• Last Updated: August 6, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)