Efficacy of Armodafinil in Moderate to Severe Obstructive Sleep Apnea Patients with Residual Excessive Daytime Sleepinesss after Suboptimal Usage of Continuous Positive Airway Pressure Treatment: A Prospective Cohort Study

Phase 3

Recruiting

• Conditions: Moderate to Severe Obstructive Sleep Apnea Patients with Residual Excessive Daytime Sleepinesss after Suboptimal Usage of Continuous Positive Airway Pressure Treatment; Obstructive sleep apnea; Armodafinil; Residual Excessive daytime sleepiness; Nearly optimal usage; continuous positive airway pressure; CPAP; OSA

• Registration Number: TCTR20210218005
• Lead Sponsor: Ratchadapiseksompoj funds

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-18
• Study Completion: 2022-04-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Patient who diagnosed with moderate to severe OSA and still have excessive daytime sleepiness defined as ESS >10 and have received stable CPAP therapy at least 4 weeks but in suboptimal usage
patient naive to Armodafinil

Exclusion Criteria

1.Patient who was diagnosed with sleep disorders other than OSA
2.Patient who has clinically significant or uncontrolled medical condition, treated and untreated, or any disorder that might interfere with drug absorption, distribution, metabolism, excretion or produce daytime sleepiness
3.Patient use prescription drugs disallowed by protocol* or clinically significant use of over-the-counter drugs within 7 days before baseline visit
4.Patient with history of alcohol, narcotics, or any other recreational drug abuse
5.Patient with excessive consumption of caffeine > 600 mg/day or > 8 cups/day
6.Patient who is pregnancy or lactation
7.Patients with psychiatric disorders
8.Patients with cardiovascular disorder
- History of Left Ventricular Hypertrophy (LVH)
- Mitral Valve Prolapse (MVP) who have experienced MVP syndrome with previous CNS stimulant exposure
- Unstable Cardiovascular (CV) disease
- Moderate to severe symptomatic Cardiovasbular (CV) disease
9.Patients with abnormal ECG at baseline or uncontrolled blood pressure ( >180/100 mmHg)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Epworth sleepiness scale 12 weeks Questionaire

Secondary Outcome Measures

Name	Time	Method
Clinical global improvement 12 weeks Questionaire,Pittsburgh sleep quality index 12 weeks Questionaire,OSLER test 12 weeks Test, non invasive,Safety variables 12 weeks ECG and physical examination with patient report,Sleep report and drink consumption Across research period Sleep diary