DAW2020 on OSA Endotypic Traits

Obstructive Sleep Apnea (OSA) Clinical Trial

— SedOSA  

Official title:

Effect of DAW2020 on Endotypic Traits in OSA

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04538755
• Other study ID #: 2020p002760-1
• Status: Enrolling by invitation
• Phase: Phase 1/Phase 2
• Start date: November 15, 2020
• Est. completion date: June 15, 2024

Study information

• Verified date: July 2023
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: June 15, 2024
• Est. primary completion date: May 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obstructive Sleep Apnea (OSA)
• Sleep Apnea, Obstructive

Intervention

Drug:
• Placebo oral capsule
Placebo before sleep
• DAW2020 oral capsule
DAW2020 34 mg 4 h before sleep, single night administration

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of DAW2020 on arousal threshold (%eupnea)	Arousal threshold will be calculated using diaphragm EMG	1 night