Pharmacological Treatment Targeting Endotypic Traits of Obstructive Sleep Apnea

Obstructive Sleep Apnea of Adult Clinical Trial

Official title:

Pharmacological Treatment Targeting Endotypic Traits of Obstructive Sleep Apnea

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06295562
• Other study ID #: CMUH112-REC3-201
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: April 1, 2024
• Est. completion date: July 31, 2025

Study information

• Verified date: March 2024
• Source: China Medical University Hospital
• Contact: Cheng, Ph.D.
• Phone: +886422052121
• Email: s871065[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will recruit 66 patients with obstructive sleep apnea, comprising 33 men and 33 women, who have been referred to the sleep center by their doctors for polysomnograms (PSG). The subjects will undergo two overnight sleep PSG sessions at the sleep center. The interval between the two examinations will be at least 7 days, during which they will receive both a placebo and medication conditions, administered 1 hour before bedtime. The study drugs will include: (1) atomoxetine 80 mg and oxybutynin 5 mg; or (2) venlafaxine 37.5 mg; or (3) atomoxetine 80 mg and trazodone 100 mg. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 66
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea of Adult
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Drug:
• Atomoxetine 80mg combined with oxybutynin 5mg
Atomoxetine 80mg combined with oxybutynin 5m
• Venlafaxine 37.5mg
Venlafaxine 37.5mg
• Atomoxetine 80mg combined with trazodone 100mg
Atomoxetine 80mg combined with trazodone 100mg
• Placebo
Placebo tablet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sleep quality	Sleep quality is assessed using a 3-point Likert scale ranging from 1 (very good) to 3 (very poor)	Baseline and one week
Other	Waking sleepiness	Waking sleepiness is assessed using a 4-point Likert scale ranging from 1 (very sleepy) to 4 (not at all sleepy).	Baseline and one week
Primary	Physiological parameter	Change in apnea-hypopnea index.	Baseline and one week
Secondary	Endotypic traits	Four endotypic traits, namely arousal threshold, upper airway collapsibility, loop gain, and upper airway muscle compensation, will be estimated using the Phenotyping Using Polysomnography method, specifically, a validated cloud-based Python application (PUPpy).	Baseline and one week