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Sleep Apnea, Obstructive | The Effects of Trazodone on Sleep Apnea Severity

Sleep Apnea, Obstructive research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Sleep Apnea, Obstructive

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Placebo pillSubjects will receive a sugar pill during the placebo arm

Drug:TrazodoneSubjects will receive trazodone during one of their treatment arm studies

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

TrazodoneSubjects will receive trazodone during their treatment night sleep study

Study Status

Completed

Start Date: March 2013

Completed Date: December 2014

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Apnea-Hypopnea Index

Secondary Outcome: Arousal Threshold (cmH2O)

Study sponsors, principal investigator, and references

Principal Investigator: David A Wellman, MD, PhD

Lead Sponsor: Brigham and Women's Hospital

Collaborator: National Heart, Lung, and Blood Institute (NHLBI)

More information:https://clinicaltrials.gov/show/NCT01817907

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