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Pharmacological Intervention for Symptomatic Mild Sleep Disordered Breathing

NCT04611750 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2022-03-02

No results posted yet for this study

Summary

Currently, there is no pharmacological intervention for mild symptomatic obstructive sleep disordered breathing (SDB) in the form of loud habitual snoring, inspiratory flow limitation (i.e. upper airway resistance syndrome), or mild sleep apnea. Here the investigators study the effect on SDB of stimulating pharyngeal muscles during sleep with AD036. The key hypothesis of the study is that AD036 is superior to placebo on self-reported and objective measures of SDB severity.

Conditions

  • Sleep Disordered Breathing

Interventions

DRUG

AD036

AD036 will be given for 14 days

DRUG

Placebo

Placebo will be given for 14 days

Sponsors & Collaborators

  • Apnimed

    collaborator INDUSTRY

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Scott A Sands, PhD · Brigham and Women's Hospital

  • Bradley A Edwards, PhD · Monash University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
25 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-02
Primary Completion
2022-01-18
Completion
2022-01-18
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Entities

Drugs

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 NCT04611750 on ClinicalTrials.gov