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NCT05293600 · ClinicalTrials.gov registry record · Phase 1

Rescue Pharmacotherapy for OSA

A Phase 1 study of Obstructive Sleep Apnea, sponsored by Brigham and Women's Hospital.

Recruiting
Registry status
Phase 1
Development phase
70
Enrollment target
1
Study location

NCT05293600 is a Phase 1 study of Obstructive Sleep Apnea that is actively recruiting participants, run by Brigham and Women's Hospital. The registered enrollment target is 70 participants, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (68% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05293600, a Phase 1 study of Obstructive Sleep Apnea, is actively recruiting participants, sponsored by Brigham and Women's Hospital.

RECRUITING
Registry status
Phase 1
Development phase
70 participants
Enrollment target
1
Study location

Study Summary

Persistent obstructive sleep apnea (OSA) is common in people treated with mandibular advancement device (MAD) or hypoglossal nerve stimulation (HGNS). For most patients, these treatments are the last line of defense. If MAD or HGNS do not work, then patients are left to suffer the consequences of undertreated OSA. In this study, the investigators want to test the addition of a drug treatment to their regimen. Endotypes will be targeted pharmacologically with one of the following drugs: acetazolamide for a high loop gain, atomoxetine-plus-eszopiclone for poor pharyngeal muscle compensation, or trazodone for a low arousal threshold. This aim is expected to provide treatment strategies for rescuing non-responders to MAD or HGNS therapy.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Acetazolamide
  • DRUG Trazodone
  • DRUG Atomoxetine and eszopiclone

Study Locations (1)

Massachusetts

  • Sleep Disorders Research Program Brigham and Women's Hospital - Boston

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2023-07-01
Est. Completion 2026-10-30
Phase Phase 1

Sponsor

Brigham and Women's Hospital

937 total trials

What the Registry Record Tells You About NCT05293600

The ClinicalTrials.gov registry entry for NCT05293600 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (68% lower). The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Obstructive Sleep Apnea appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.

NCT05293600 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.

Frequently Asked Questions

What is clinical trial NCT05293600 about?

NCT05293600 is a clinical study titled "Rescue Pharmacotherapy for OSA". Persistent obstructive sleep apnea (OSA) is common in people treated with mandibular advancement device (MAD) or hypoglossal nerve stimulation (HGNS). For most patients, these treatments are the last line of defense. If MAD or HGNS do not work, then patients are left to suffer the consequences of un...

What is the current status of trial NCT05293600?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2023-07-01. Estimated completion is 2026-10-30.

What conditions does trial NCT05293600 study?

This clinical trial studies the following conditions: Obstructive Sleep Apnea.

What interventions are being tested in trial NCT05293600?

The interventions under investigation include: Placebo (DRUG), Acetazolamide (DRUG), Trazodone (DRUG), Atomoxetine and eszopiclone (DRUG).

Who is sponsoring clinical trial NCT05293600?

This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05293600 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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