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Effect of AD128 to Treat Obstructive Sleep Apnea

NCT04394143 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2021-08-06

No results posted yet for this study

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

Interventions

DRUG

AD128

Oral administration of two capsules before sleep for 7 days.

DRUG

Mannitol

Oral administration of two capsules before sleep for 7 days.

Sponsors & Collaborators

  • Apnimed

    collaborator INDUSTRY

  • Raphael Heinzer

    lead OTHER

Principal Investigators

  • Raphael Heinzer, MD · University Hospital of Lausanne (CHUV)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-20
Primary Completion
2021-07-19
Completion
2021-07-19

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04394143 on ClinicalTrials.gov