N/A
N=15
The Effects of Trazodone on Sleep Apnea Severity
Sleep Apnea, Obstructive
Bottom Line
View on ClinicalTrials.gov: NCT01817907 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcome: Primary: Apnea-Hypopnea Index — 38.7; 28.5 events/hour
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Placebo pill (Drug); Trazodone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Apnea-Hypopnea Index |
38.7; 28.5 | — |
| SECONDARY Arousal Threshold (cmH2O) |
-19.3; -20.3 | 0.52 |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01817907). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.