Trazodone on OSA Endotypes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Placebo oral tablet, Trazodone Hydrochloride.
- Who it may be relevant to
- Registry conditions: Obstructive Sleep Apnea. Basic parameters: 21 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Trazodone on Obstructive Sleep Apnea Endotypes and Severity
Overview
Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. Some OSA patients with low arousal threshold wake up prematurely during an obstructive event and do not have time for spontaneous upper airway (UA) dilator muscle recruitment. As a consequence they are exposed to apnea and hypopnea cycling. In this protocol the investigators will test the effect of trazodone administered before sleep on OSA traits and OSA severity during sleep.
Detailed description
Two overnight home sleep studies will be performed: a drug night and a placebo night. The patient will breath spontaneously (without CPAP) for both nights. On the study nights, subjects be instrumented with a full polygraphy for monitoring sleep, and respiratory events. Trazodone 100 mg will be given 30 min before lights out. At least four hours of sleep with high quality signal acquisition will be required for a study to be judged adequate. After the first overnight study is completed, there will be a one-week washout period prior to crossing over to the other treatment.
Interventions
- Drug Placebo oral tablet
Placebo capsule taken 30 min before sleep - Drug Trazodone Hydrochloride
Trazodone 100 mg 30 min before sleep
Primary outcome measures
- Effect of trazodone on arousal threshold (%eupnea) [Time frame: 1 night]
Secondary outcome measures (1)
- Effect of trazodone on apnea hypopnea index (events/h) [Time frame: 1 night]
Eligibility criteria
Inclusion criteria
- Moderate-to-severe OSA (AHI ≥ 15 events/hr)
Exclusion criteria
- All participants will be healthy and without major organ system disease that would preclude undergoing the physiological measurements.
- Use of medications expected to stimulate or depress respiration (including opioids, barbiturates, acetazolamide, doxapram, almitrine, theophylline, 4-hydroxybutanoic acid).
- Use of SNRIs/SSRIs.
- Conditions likely to affect OSA physiology: neuromuscular disease or other major neurological disorder, heart failure (also below), or any other unstable major medical condition.
- Sleep disordered breathing or respiratory disorders other than obstructive sleep apnea:
- Other sleep disorders: periodic limb movements (periodic limb movement arousal index > 10/hr), narcolepsy, or parasomnias.
- Hypersensitivity to the study drug (angioedema or urticaria)
- Contraindications to DAW2020
- Use of medications that lengthen QTc interval
- Hypokaliemia, hypomagnesemia, uncontrolled thyroid disease
- Severe claustrophobia.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Brigham and Women's Hospital — Boston
Identifiers
NCT: NCT06286189 · 2020P002760-t