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DAW1033B2 in Obstructive Sleep Apnea (OsaStimB2)

Primary Purpose

Obstructive Sleep Apnea (OSA)

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Placebo oral capsule
DAW1033B2 oral capsule
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea (OSA)

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criterion:

  • OSA: AHI > 15

Exclusion Criteria:

  • Any medical condition other than well controlled hypertension, diabetes, hyperlipidemia
  • Any medication known to influence breathing, sleep/arousal or muscle physiology.
  • Claustrophobia.
  • Inability to sleep supine.
  • Allergy to lidocaine, Oxymetazoline HCl, DAW1033D.
  • Individuals with underlying cardiac disease, such as arrhythmias.
  • Individuals taking psychiatric medications, or any of the studied medications for medical care.
  • History of seizures
  • For women: Pregnancy.
  • History of panic disorder / hyperventilation syndrome / Attention deficit-hyperactivity disorder (ADHD) / autism

Sites / Locations

  • Sleep Disorders Research Program Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

DAW1033B2 oral capsule

Arm Description

Placebo before sleep

DAW1033B2 before sleep

Outcomes

Primary Outcome Measures

Apnea Hypopnea Index (AHI, Events/Hour of Sleep)
Based on previous studies the investigators anticipate that DAW1032B2 will reduce AHI more effectively in subjects with moderate sleep apnea, mildly obese (BMI<32), Vpassive > 50% of Veupnea (ventilation during eupneic ventilatory drive)

Secondary Outcome Measures

Full Information

First Posted
February 2, 2018
Last Updated
February 11, 2020
Sponsor
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03426631
Brief Title
DAW1033B2 in Obstructive Sleep Apnea
Acronym
OsaStimB2
Official Title
Effect of DAW1033B2 on Obstructive Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 15, 2017 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
January 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. OSA patients show a marked reduction in upper airway (UA) dilator muscle activity at sleep onset and this phenomenon leads to increased collapsibility of UA compared to normal subjects. In this protocol the investigators will test the effect of DAW1033B2 administered before sleep on OSA phenotype traits and OSA severity during sleep.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea (OSA)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo before sleep
Arm Title
DAW1033B2 oral capsule
Arm Type
Experimental
Arm Description
DAW1033B2 before sleep
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Intervention Description
Placebo capsule 30 minutes before sleep
Intervention Type
Drug
Intervention Name(s)
DAW1033B2 oral capsule
Intervention Description
DAW1033B2 capsule 30 minutes before sleep
Primary Outcome Measure Information:
Title
Apnea Hypopnea Index (AHI, Events/Hour of Sleep)
Description
Based on previous studies the investigators anticipate that DAW1032B2 will reduce AHI more effectively in subjects with moderate sleep apnea, mildly obese (BMI<32), Vpassive > 50% of Veupnea (ventilation during eupneic ventilatory drive)
Time Frame
1 night

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criterion: OSA: AHI > 15 Exclusion Criteria: Any medical condition other than well controlled hypertension, diabetes, hyperlipidemia Any medication known to influence breathing, sleep/arousal or muscle physiology. Claustrophobia. Inability to sleep supine. Allergy to lidocaine, Oxymetazoline HCl, DAW1033D. Individuals with underlying cardiac disease, such as arrhythmias. Individuals taking psychiatric medications, or any of the studied medications for medical care. History of seizures For women: Pregnancy. History of panic disorder / hyperventilation syndrome / Attention deficit-hyperactivity disorder (ADHD) / autism
Facility Information:
Facility Name
Sleep Disorders Research Program Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

DAW1033B2 in Obstructive Sleep Apnea

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