NCT01817907

Brief Summary

In Obstructive sleep apnea (OSA), the upper airway closes over and over again during sleep. This leads to disrupted sleep (waking up during the night), daytime sleepiness, and an increased risk for developing high blood pressure. Currently, the best treatment for obstructive sleep apnea is sleeping with a mask that continuously blows air into the nose (i.e. Continuous positive airway pressure \[CPAP\] treatment). While CPAP treatment stops the upper airway from closing in most people, many people have difficulty sleeping with the mask in place and therefore do not use the CPAP treatment. This research study is being conducted to learn whether using a sedative will improve OSA severity by altering some of the traits that are responsible for the disorder.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2013

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

November 22, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 26, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

February 24, 2017

Completed
Last Updated

February 24, 2017

Status Verified

January 1, 2017

Enrollment Period

1.1 years

First QC Date

November 22, 2012

Results QC Date

November 1, 2016

Last Update Submit

January 6, 2017

Conditions

Sleep Apnea, Obstructive

Keywords

Apnea- Hypopnea indexArousal Threshold

Outcome Measures

Primary Outcomes (1)

  • Apnea-Hypopnea Index

    The Apnea-Hypopnea Index (AHI) is an index of sleep apnea severity that encompasses the frequency of apneas (cessations in breathing) and hypopneas (reductions in airflow).

    Participants will be assessed on 2 nights over an average period of 2 weeks.

Secondary Outcomes (1)

  • Arousal Threshold (cmH2O)

    Participants will be assessed on 2 nights over an average period of 2 weeks.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Subjects will receive a sugar pill during their placebo night sleep study.

Drug: Placebo pill

Trazodone

ACTIVE COMPARATOR

Subjects will receive trazodone during their treatment night sleep study

Drug: Trazodone

Interventions

Placebo pillDRUG

Subjects will receive a sugar pill during the placebo arm

Also known as: Sugar pill
Placebo
TrazodoneDRUG

Subjects will receive trazodone during one of their treatment arm studies

Trazodone

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • OSA (elevated AHI).
  • Age range 18-70 years.

You may not qualify if:

  • Any known cardiac (apart from treated hypertension), pulmonary (including asthma), renal, neurologic (including epilepsy), neuromuscular, or hepatic disease.
  • Susceptible to stomach ulcers.
  • Pregnant women.
  • History of hypersensitivity to Afrin, Lidocaine, trazodone and/or donepezil.
  • History of bleeding diathesis and/or gastrointestinal bleeding.
  • Use of any medications that may affect sleep or breathing.
  • A psychiatric disorder, other than mild depression; e.g. schizophrenia, bipolar disorder, major depression, panic or anxiety disorders.
  • Substantial cigarette (\>5/day), alcohol (\>3oz/day) or use of illicit drugs.
  • More than 10 cups of beverages with caffeine (coffee, tea, soda/pop) per day.
  • Desaturations to below 70% lasting greater than 10 seconds in duration per event on polysomnography.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • Smales ET, Edwards BA, Deyoung PN, McSharry DG, Wellman A, Velasquez A, Owens R, Orr JE, Malhotra A. Trazodone Effects on Obstructive Sleep Apnea and Non-REM Arousal Threshold. Ann Am Thorac Soc. 2015 May;12(5):758-64. doi: 10.1513/AnnalsATS.201408-399OC.

    PMID: 25719754DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

SugarsTrazodone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

CarbohydratesPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyridonesPyridines

Results Point of Contact

Title
D. Andrew Wellman
Organization
Brigham and women's Hospital
awellman@rics.bwh.harvard.edu
617-732-8483

Study Officials

  • David A Wellman, MD, PhD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 22, 2012

First Posted

March 26, 2013

Study Start

March 1, 2013

Primary Completion

April 1, 2014

Study Completion

December 1, 2014

Last Updated

February 24, 2017

Results First Posted

February 24, 2017

Record last verified: 2017-01

Locations

US(1)