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DAW2020 on OSA Endotypic Traits (SedOSA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04538755
Recruitment Status : Not yet recruiting
First Posted : September 4, 2020
Last Update Posted : September 9, 2020
Sponsor:
Information provided by (Responsible Party):
David Andrew Wellman, Brigham and Women's Hospital

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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea (OSA) Drug: Placebo oral capsule Drug: DAW2020 oral capsule Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of DAW2020 on Endotypic Traits in OSA
Estimated Study Start Date : November 15, 2020
Estimated Primary Completion Date : June 15, 2022
Estimated Study Completion Date : July 15, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo capsule 4 hours before sleep
Drug: Placebo oral capsule
Placebo before sleep

Active Comparator: DAW2020
DAW2020 capsule 4 hours before sleep
Drug: DAW2020 oral capsule
DAW2020 34 mg 4 h before sleep, single night administration




Primary Outcome Measures :
  1. Effects of DAW2020 on arousal threshold (%eupnea) [ Time Frame: 1 night ]
    Arousal threshold will be calculated using diaphragm EMG



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04538755


Contacts
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Contact: David A Wellman, MD 617-732-6541 awellman@rics.bwh.harvard.edu

Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
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Responsible Party: David Andrew Wellman, Associate professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT04538755    
Other Study ID Numbers: 2020p002760-1
First Posted: September 4, 2020    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases