Status:
COMPLETED
The Effects of Trazodone on Sleep Apnea Severity
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Sleep Apnea, Obstructive
Eligibility:
All Genders
18-70 years
Phase:
NA
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 de...
Detailed Description
Obstructive sleep apnea (OSA) is characterized by repetitive collapse or 'obstruction' of the pharyngeal airway during sleep. These obstructions result in repetitive hypopneas/apneas and intermittent ...
Eligibility Criteria
Inclusion
- Inclusion Criteria for OSA Patients:
- OSA (elevated AHI).
- Age range 18-70 years.
- Exclusion Criteria:
- 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.
Exclusion
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01817907
Start Date
March 1 2013
End Date
December 1 2014
Last Update
February 24 2017
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115