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Rescue Pharmacotherapy for Obstructive Sleep Apnea (RescOSA Trial)

Phase 1 & 2

Recruiting

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Individuals who have failed MAD or HGNS therapy, defined as a residual AHI ≥ 15 events/hr on MAD or HGNS therapy.

Be older than 18 years old

Must not have

Any unstable major medical condition.

Other sleep disorders: periodic limb movements (periodic limb movement index > 20/hr), narcolepsy, or parasomnias.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 night

Summary

This trial is testing whether adding a drug to the treatment regimen of people who haven't responded to other treatments can help them. The drugs being tested are acetazolamide, atomoxetine-plus-eszopiclone, or trazodone.

Who is the study for?

This trial is for individuals with persistent obstructive sleep apnea (OSA) who haven't found relief through mandibular advancement device (MAD) or hypoglossal nerve stimulation (HGNS). Participants must have a residual AHI of ≥15 events/hr despite these treatments. People with certain medical conditions, including severe liver or kidney issues, specific heart problems, glaucoma, and those on conflicting medications like SSRIs/SNRIs are excluded.

What is being tested?

The study tests whether adding one of several drugs—acetazolamide, atomoxetine-plus-eszopiclone, trazodone—or a placebo can improve OSA in patients unresponsive to MAD or HGNS. Each drug targets different physiological traits contributing to OSA such as high loop gain or low arousal threshold.

What are the potential side effects?

Potential side effects include acid-base balance issues and electrolyte disturbances from acetazolamide; dry mouth, constipation, increased heart rate from atomoxetine; drowsiness from eszopiclone; and sedation or cardiac changes from trazodone. Individual reactions may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My sleep apnea treatment with a device hasn't reduced my symptoms enough.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any unstable major health conditions.

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I have a sleep disorder like restless legs, narcolepsy, or unusual behaviors during sleep.

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I am not taking any medications that affect my breathing.

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I have a breathing or lung disorder other than obstructive sleep apnea.

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I do not have any health conditions that would make atomoxetine unsafe for me.

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I do not have allergies to eszopiclone, COPD, am not pregnant or breastfeeding, and do not have liver disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 night

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 night

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 night for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Apnea Hypopnea Index (AHI, Events/Hour of Sleep)

Secondary study objectives

Arousal Index (AI, Events/Hours of Sleep)

Nadir oxygen saturation during sleep (LSpO2, %)

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Interventional armActive Control3 Interventions

This is a two arm study. Patients will receive only one of the following drugs based on their altered sleep apnea trait. Patients with decreased arousal threshold will undergo treatment with placebo or Trazodone 100 mg in random order (one pill before 30 minutes before bedtime), patients with decreased pharyngeal muscle responsiveness will undergo treatment with placebo or Atomoxetine 80 mg + Eszopiclone 3 mg in random order (one pill before 30 minutes before bedtime), patients with increased loop gain will undergo treatment with placebo or Acetazolamide 500 mg in random order (one pill before 30 minutes before bedtime).

Group II: PlaceboPlacebo Group1 Intervention

0 / 7Eligibility criteria met