AD109 for Obstructive Sleep Apnea

Recruiting at 63 trial locations

Overseen By Luigi Taranto, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Apnimed

Must not be taking: Sedative-hypnotics

Disqualifiers: Narcolepsy, Insomnia, Cardiac disease, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

660 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a specific combination of medications called AD109 to see if it helps people with Obstructive Sleep Apnea. The goal is to find out if AD109 can keep airways open during sleep. The study will last for several months and compare the effects of AD109.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are using sedative-hypnotics or other medications for insomnia, you may not be eligible to participate.

How does the drug AD109 for obstructive sleep apnea differ from other treatments?

The research provided does not contain specific information about AD109, so I cannot determine how it differs from other treatments for obstructive sleep apnea. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for adults over 18 with Obstructive Sleep Apnea (OSA) who have an AHI >5, don't respond well to PAP therapy, and feel very tired. They should not be too overweight (BMI limits apply differently for men and women). People with certain sleep disorders, severe heart issues, or significant neurological diseases cannot join.

Inclusion Criteria

PROMIS-Fatigue: raw score ≥17

My BMI is between 18.5 and 40 (if I am a man) or 42 (if I am a woman).

PSG criteria: AHI of >5; ≤ 25% central or mixed apneas; and PLM arousal index ≤15

Exclusion Criteria

I have been diagnosed with narcolepsy, restless leg syndrome, or REM sleep behavior disorder.

I have trouble falling or staying asleep, or I've used sleep medication in the last month.

I have a craniofacial syndrome or very large tonsils.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either AD109 or placebo in a double-blind manner

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• AD109
• Placebo

Trial Overview The study tests AD109 against a placebo in people with OSA. It's a year-long test where participants are randomly chosen to receive either the real drug or a fake one without knowing which they're getting. The goal is to see if AD109 helps better than the placebo.

Participant Groups

Group I: AD109 Experimental Treatment 1 Intervention

AD109

Group II: Placebo Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

Apnimed

Lead Sponsor

Trials

17

Recruited

3,400+

Findings from Research

In a study involving 104 participants with mild to moderate obstructive sleep apnea, the use of sham-CPAP showed statistically significant but small changes in sleep quality, indicating it can serve as an effective placebo in clinical trials.

The differences observed in sleep metrics, such as decreased sleep efficiency and increased arousal, suggest that while sham-CPAP impacts sleep, these effects are minimal and clinically insignificant, supporting its use in evaluating true CPAP treatment effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of sham-CPAP as a placebo in CPAP intervention studies. Rodway, GW., Weaver, TE., Mancini, C., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Evaluation of sham-CPAP as a placebo in CPAP intervention studies. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Success in blinding to group assignment with sham-CPAP. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of continuous positive airway pressure in mild obstructive sleep apnea. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Placebo response in objective and subjective measures of hypersomnia in randomized clinical trials on obstructive sleep apnea. A systematic review and meta-analysis. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

A crossover study comparing the efficacy of continuous positive airway pressure with anterior mandibular positioning devices on patients with obstructive sleep apnea. [2019]