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NCT Number: NCT04445688

Crossover Trial of AD036 in Obstructive Sleep Apnea

This is a randomized, 3-Period, Placebo-Controlled, Crossover, phase 2 clinical study to examine the efficacy and safety of AD036 versus placebo or atomoxetine in patients with obstructive sleep apnea.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Preferred Research Partners, Inc., Little Rock, Arkansas, United States

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About this study

The study is designed to examine the efficacy and safety of AD036 to treat obstructive sleep apnea. The study is a three-period single-dose randomized crossover design in which patients will undergo overnight Home Sleep Apnea Testing (HSAT) with dosing of one of the following 3 treatments: AD036, Atomoxetine, or Placebo. Participants will return 1 week after their final crossover HSAT for an end of study (EOS) Visit.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or Female, between 25 to 65 years of age, inclusive, at the Screening Visit.
  • AHI 10 to <20, or AHI ≥20 if meets PSG criteria

Exclusion criteria

  • History of narcolepsy.
  • Clinically significant craniofacial malformation.
  • Clinically significant cardiac disease (e.g., rhythm disturbances, coronary artery disease or cardiac failure) or hypertension requiring more than 2 medications for control. A medication for these purposes is defined by dosage form, such that a combination antihypertensive medication is considered 1 medication
  • CPAP should not be used for at least 2 weeks prior to first study PSG
  • History of using oral or nasal devices for the treatment of OSA may enroll as long as the devices are not used during participation in the study.

Treatment and study plan

AD036

Drug

Oral administration before bed

Atomoxetine

Drug

Oral administration before bed

Placebo

Drug

Oral administration before bed

Primary outcomes

  1. Apnea-Hypopnea Index

    Time frame: 1 day

    Apnea-Hypopnea Index(Disease severity is often defined based on the number of apneas and hypopneas per hour during sleep), AD036 vs. placebo

Secondary outcomes

  1. Hypoxic Burden

    Time frame: 1 day

    Hypoxic burden (a way to measure oxygen desaturation) determined by measuring the respiratory event-associated area under the desaturation curve from pre-event baseline, AD036 vs. placebo. Hypoxic Burden was measured during polysomnography (type of sleep study), while the patient was asleep

  2. ODI

    Time frame: 1 day

    Oxygen Desaturation Index, measured by pulse-oximetry, AD036 vs. placebo

Sponsors and collaborators

Lead sponsor

Apnimed

Industry

Registry information

Official study title

Phase 2, Randomized, 3-Period, Placebo-Controlled Crossover Study to Evaluate the Efficacy and Safety in Obstructive Sleep Apnea of AD036 Versus Placebo or Atomoxetine

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 24, 2020
Registry last updated
Sep 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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