NCT05350215

Brief Summary

Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. In previous research atomoxetine and oxybutynin showed promising effect at reducing OSA severity, however they reduced arousal threshold, one of the key traits responsible for OSA. Since oxybutynin was used mainly as a hypnotic, but it is burdened by several anti-cholinergic side effects, DAW2020, a hypnotic which prolonged the total sleep time in a previous trial in OSA patients, could be a better candidate to associate with atomoxetine.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
1mo left

Started Jun 2022

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Jun 2022Jun 2026

First Submitted

Initial submission to the registry

April 22, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 28, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

March 3, 2026

Status Verified

March 1, 2026

Enrollment Period

4 years

First QC Date

April 22, 2022

Last Update Submit

March 1, 2026

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

  • Effect of atomoxetine and DAW2020 on OSA severity

    OSA severity will be quantified by the number of respiratory events/h (AHI)

    1 week

Secondary Outcomes (2)

  • Effect of atomoxetine and DAW2020 on arousal index

    1 week

  • Effect of atomoxetine and DAW2020 on nadir oxygen desaturation

    1 week

Study Arms (2)

Placebo oral capsules

PLACEBO COMPARATOR

Placebo (2 pills) before sleep for a week

Drug: Placebo oral capsule

Atomoxetine and DAW2020 oral capsules

ACTIVE COMPARATOR

DAW2020 34 mg 4 h before sleep, single night administration for a week. Simultaneous administration of atomoxetine 40 mg for 3 days 30 min before sleep, 80 mg for the following 4 days, 30 min before sleep

Drug: Atomoxetine Oral Capsule [Strattera]

Interventions

Placebo oral capsuleDRUG

Placebo pills for a week, 1 pill 4 hr before sleep and 1 pill 30 min before sleep

Placebo oral capsules
Atomoxetine Oral Capsule [Strattera]DRUG

Atomoxetine for a week: 40 mg for 3 days 30 min before sleep, 80 mg for 4 days 30 min before sleep Simultaneous administration of DAW2020 for a week, 34 mg 4 h before sleep

Also known as: DAW2020 Oral Capsule
Atomoxetine and DAW2020 oral capsules

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02135, United States

RECRUITING

Related Publications (1)

  • Messineo L, Preuss M, Azarbarzin A, Vena D, Gell L, Aishah A, Esmaeili N, Kim M, Burdick I, Chen T, White D, Sands SA, Wellman A. Effects of the Combination of Pimavanserin and Atomoxetine on OSA Severity: A Randomized Crossover Trial. Chest. 2025 Jul;168(1):223-235. doi: 10.1016/j.chest.2025.03.013. Epub 2025 Mar 28.

    PMID: 40158847DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Central Study Contacts

Ludovico Messineo, MD, PhD

CONTACT

18572726188lmessineo@bwh.harvard.edu

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

April 22, 2022

First Posted

April 28, 2022

Study Start

June 1, 2022

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

March 3, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)