DAW2020 on OSA Endotypic Traits (SedOSA)
Primary Purpose
Obstructive Sleep Apnea (OSA)
Status
Enrolling by invitation
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Placebo oral capsule
DAW2020 oral capsule
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea (OSA)
Eligibility Criteria
Inclusion Criteria:
- Moderate-to-severe OSA (AHI ≥ 15 events/hr)
Exclusion Criteria:
- All participants will be healthy and without major organ system disease that would preclude undergoing the physiological measurements.
- Use of medications expected to stimulate or depress respiration (including opioids, barbiturates, acetazolamide, doxapram, almitrine, theophylline, 4-hydroxybutanoic acid).
- Use of SNRIs/SSRIs.
- Conditions likely to affect OSA physiology: neuromuscular disease or other major neurological disorder, heart failure (also below), or any other unstable major medical condition.
- Sleep disordered breathing or respiratory disorders other than obstructive sleep apnea:
- Other sleep disorders: periodic limb movements (periodic limb movement arousal index > 10/hr), narcolepsy, or parasomnias.
- Hypersensitivity to the study drug (angioedema or urticaria)
- Contraindications to DAW2020
- Use of medications that lengthen QTc interval
- Hypokaliemia, hypomagnesemia, uncontrolled thyroid disease
- Severe claustrophobia.
Sites / Locations
- Brigham and Women's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
DAW2020
Arm Description
Placebo capsule 4 hours before sleep
DAW2020 capsule 4 hours before sleep
Outcomes
Primary Outcome Measures
Effects of DAW2020 on arousal threshold (%eupnea)
Arousal threshold will be calculated using diaphragm EMG
Secondary Outcome Measures
Full Information
NCT ID
NCT04538755
First Posted
August 31, 2020
Last Updated
July 5, 2023
Sponsor
Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04538755
Brief Title
DAW2020 on OSA Endotypic Traits
Acronym
SedOSA
Official Title
Effect of DAW2020 on Endotypic Traits in OSA
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 15, 2020 (Actual)
Primary Completion Date
May 15, 2024 (Anticipated)
Study Completion Date
June 15, 2024 (Anticipated)
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
Yes
5. Study Description
Brief Summary
Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. Some OSA patients with low arousal threshold wake up prematurely during an obstructive event and do not have time for spontaneous upper airway (UA) dilator muscle recruitment. As a consequence they are exposed to apnea and hypopnea cycling. In this protocol the investigators will test the effect of DAW2020 administered before sleep on OSA phenotype traits and OSA severity during sleep.
Detailed Description
Two overnight sleep studies will be performed: a drug night and a placebo night. The patient will breath spontaneously (without CPAP) for both nights. On the study nights, subjects will present to the laboratory in the evening and be instrumented with a full polysomnigraphy for monitoring sleep, physiological variables (endotypes), and respiratory events. A history and physical examination will be performed on each night prior to beginning the study, as will a urine pregnancy test in premenopausal women. DAW2020 34 mg will be given 4 hours before lights out. Subjects will sleep at least 50% of the night in the supine position. At least four hours of sleep with high quality signal acquisition will be required for a study to be judged adequate. After the first overnight study is completed, there will be a one-week washout period prior to crossing over to the other treatment.
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
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsule 4 hours before sleep
Arm Title
DAW2020
Arm Type
Active Comparator
Arm Description
DAW2020 capsule 4 hours before sleep
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Intervention Description
Placebo before sleep
Intervention Type
Drug
Intervention Name(s)
DAW2020 oral capsule
Intervention Description
DAW2020 34 mg 4 h before sleep, single night administration
Primary Outcome Measure Information:
Title
Effects of DAW2020 on arousal threshold (%eupnea)
Description
Arousal threshold will be calculated using diaphragm EMG
Time Frame
1 night
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Moderate-to-severe OSA (AHI ≥ 15 events/hr)
Exclusion Criteria:
All participants will be healthy and without major organ system disease that would preclude undergoing the physiological measurements.
Use of medications expected to stimulate or depress respiration (including opioids, barbiturates, acetazolamide, doxapram, almitrine, theophylline, 4-hydroxybutanoic acid).
Use of SNRIs/SSRIs.
Conditions likely to affect OSA physiology: neuromuscular disease or other major neurological disorder, heart failure (also below), or any other unstable major medical condition.
Sleep disordered breathing or respiratory disorders other than obstructive sleep apnea:
Other sleep disorders: periodic limb movements (periodic limb movement arousal index > 10/hr), narcolepsy, or parasomnias.
Hypersensitivity to the study drug (angioedema or urticaria)
Contraindications to DAW2020
Use of medications that lengthen QTc interval
Hypokaliemia, hypomagnesemia, uncontrolled thyroid disease
Severe claustrophobia.
Facility Information:
Facility Name
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
Citations:
PubMed Identifier
35947827
Citation
Messineo L, Gell L, Calianese N, Sofer T, Vena D, Azarbarzin A, Labarca G, Taranto-Montemurro L, Yang HC, Wang TY, Kim M, Smith H, White D, Sands S, Wellman A. Effect of Pimavanserin on the Respiratory Arousal Threshold from Sleep: A Randomized Trial. Ann Am Thorac Soc. 2022 Dec;19(12):2062-2069. doi: 10.1513/AnnalsATS.202205-419OC.
Results Reference
derived
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DAW2020 on OSA Endotypic Traits
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