Effect of AD128 to Treat Obstructive Sleep Apnea

NCT ID: NCT04394143

Last Updated: 2021-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-20
• Study Completion Date: 2021-07-19

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

AD128

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

Group Type: EXPERIMENTAL

AD128

Intervention Type: DRUG

Oral administration of two capsules before sleep for 7 days.

placebo

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

Group Type: PLACEBO_COMPARATOR

Mannitol

Intervention Type: DRUG

Oral administration of two capsules before sleep for 7 days.

Interventions

AD128

Oral administration of two capsules before sleep for 7 days.

Intervention Type: DRUG

Mannitol

Oral administration of two capsules before sleep for 7 days.

Intervention Type: DRUG

Other Intervention Names

Placebo

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Apnimed

INDUSTRY

Sponsor Role: collaborator

Raphael Heinzer

OTHER

Sponsor Role: lead

Responsible Party

Raphael Heinzer

Prof. Raphael Heinzer

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Raphael Heinzer, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Lausanne (CHUV)

Locations

Centre Hospitalier Universitaire Vaudois

Lausanne, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 36861433 (View on PubMed)

Other Identifiers

2020-00315

Identifier Type: -

Identifier Source: org_study_id