DAW2020 on OSA Endotypic Traits

NCT04538755 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: 2020p002760-1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea (OSA)

Outcome Measures

Primary Outcomes (1)

• Effects of DAW2020 on arousal threshold (%eupnea)

  Arousal threshold will be calculated using diaphragm EMG

  1 night

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo capsule 4 hours before sleep

Drug: Placebo oral capsule

DAW2020

ACTIVE COMPARATOR

DAW2020 capsule 4 hours before sleep

Drug: DAW2020 oral capsule

Interventions

Placebo oral capsule DRUG

Placebo before sleep

Placebo

DAW2020 oral capsule DRUG

DAW2020 34 mg 4 h before sleep, single night administration

DAW2020

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Moderate-to-severe OSA (AHI ≥ 15 events/hr)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• 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.

  PMID: 35947827 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of Medicine

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 4, 2020
• Study Start: November 15, 2020
• Primary Completion: May 15, 2024
• Study Completion: June 15, 2024
• Last Updated: July 7, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)