Obstructive Sleep Apnea of Adult
Conditions
Keywords
compensation, upper airway, Taiwan, serotonin, noradrenaline
Brief summary
This study will conduct 3 intervention trials with 44 different participants in each trial, with 22 participants will undergo in-laboratory overnight polysomnograms (PSGs) at one night of medication intervention, and the other 22 at taking placebo (contained starch) 1 h before sleep. Three medication regimens will be tested: (1) atomoxetine 80mg combined with oxybutynin 5mg; (2) venlafaxine 37.5mg; and (3) oxybutynin 5mg combined with trazodone 100mg. Endotypic traits will be estimated using the Phenotyping Using Polysomnography method. The primary outcome is the change in apnea-hypopnea index, and secondary outcomes include endotypic traits and sleep parameters.
Interventions
DRUGAtomoxetine 80mg combined with oxybutynin 5mg
Atomoxetine 80mg combined with oxybutynin 5mg
DRUGVenlafaxine 37.5mg
Venlafaxine 37.5mg
DRUGoxybutynin 5mg combined with trazodone 100mg
oxybutynin 5mg combined with trazodone 100mg
DRUGPlacebo
Placebo tablet
Sponsors
China Medical University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* apnea-hypopnea index ≥ 15 hr-¹
Exclusion criteria
* the presence of pulmonary, cardiac, neurologic, or other active severe medical or psychiatric diseases * current use of continuous positive airway pressure therapy * use of drugs that might interact with the investigational medication or known to affect sleep during the trial or 1 month before the study * known allergy to the investigational medication * current smoking * heavy alcohol drinking (male \> 14 drinks and women \>7 drinks per week) * pregnant or lactating * periodic limb movement index \> 15hr-1 * the presence of sleep-related hypoventilation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnea-hypopnea index | Pre-intervention and after single night intervention | Change in apnea-hypopnea index. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Arousal threshold | Pre-intervention and after single night intervention | Endotyping using polysomnography will be estimated with the PUP method. |
| Upper airway collapsibility | Pre-intervention and after single night intervention | Endotyping using polysomnography will be estimated with the PUP method. |
| Loop gain | Pre-intervention and after single night intervention | Endotyping using polysomnography will be estimated with the PUP method. |
| Upper airway muscle compensation | Pre-intervention and after single night intervention | Endotyping using polysomnography will be estimated with the PUP method. |
Countries
Taiwan
Outcome results
None listed