NCT03383887

Brief Summary

Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. OSA patients show a marked reduction in upper airway (UA) dilator muscle activity at sleep onset and this phenomenon leads to increased collapsibility of UA compared to normal subjects. In this protocol the investigators will test the effect of DAW1033D administered before sleep on OSA phenotype traits and OSA severity during sleep.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2017

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

December 13, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

December 13, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 27, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2020

Completed
16 days until next milestone

Results Posted

Study results publicly available

February 5, 2020

Completed
Last Updated

February 25, 2020

Status Verified

February 1, 2020

Enrollment Period

2.1 years

First QC Date

December 13, 2017

Results QC Date

January 22, 2020

Last Update Submit

February 11, 2020

Conditions

Obstructive Sleep Apnea (OSA)

Outcome Measures

Primary Outcomes (1)

  • Apnea Hypopnea Index (AHI, Events/Hour of Sleep)

    Based on previous studies the investigators anticipate that DAW1033D will reduce AHI more effectively in subjects with moderate sleep apnea, and mild to moderate pharyngeal collapsibility. AHI describes the frequency of obstruction of the upper airway during sleep and is commonly used to describe the presence and severity of obstructive sleep apnea.

    1 night

Secondary Outcomes (1)

  • Collapsibility of the Upper Airway: VPassive

    1 night

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo capsule 30 minutes before sleep

Drug: Placebo oral capsule

DAW1033D

ACTIVE COMPARATOR

DAW1033D capsule 30 minutes before sleep

Drug: DAW1033D oral capsule

Interventions

Placebo oral capsuleDRUG

Placebo before sleep

Placebo
DAW1033D oral capsuleDRUG

DAW1033D before sleep

DAW1033D

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- AHI \> 15

You may not qualify if:

  • Any medical condition other than well controlled hypertension, diabetes, hyperlipidemia
  • Any medication known to influence breathing, sleep/arousal or muscle physiology.
  • Claustrophobia.
  • Inability to sleep supine.
  • Allergy to lidocaine, Oxymetazoline HCl, DAW1033D.
  • Individuals with underlying cardiac disease, such as arrhythmias.
  • Individuals taking psychiatric medications, or any of the studied medications for medical care.
  • History of seizures
  • For women: Pregnancy.
  • History of panic disorder / hyperventilation syndrome / Attention deficit-hyperactivity disorder (ADHD) / autism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sleep Disorders Research Program Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • Taranto-Montemurro L, Sands S, Azarbarzin A, Calianese N, Vena D, Hess L, Kim SW, White DP, Wellman A. Impact of cold and flu medication on obstructive sleep apnoea and its underlying traits: A pilot randomized controlled trial. Respirology. 2021 May;26(5):485-492. doi: 10.1111/resp.14009. Epub 2021 Jan 24.

    PMID: 33491327DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Luigi Taranto Montemurro, MD
Organization
Brigham and Women's Hospital
ltarantomontemurro@bwh.harvard.edu
6177326541

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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 HMS

Study Record Dates

First Submitted

December 13, 2017

First Posted

December 27, 2017

Study Start

December 13, 2017

Primary Completion

January 20, 2020

Study Completion

January 20, 2020

Last Updated

February 25, 2020

Results First Posted

February 5, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)