Cross-over Study of Armodafinil Treatment of Daytime Sleepiness Associated With Treated Nocturia
- Registration Number
- NCT02151253
- Lead Sponsor
- Duke University
- Brief Summary
The objective of the study is to evaluate armodafinil as a wakefulness-promoting therapy as a means of improving residual daytime sleepiness in patients with treated nocturia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 81
Inclusion Criteria
- Receiving standard-of-care therapy for nocturia based on assessment by study physician
- Evaluation by study physician indicates that the patient meets criteria for either overactive bladder diagnosis, or nocturnal polyuria diagnosis.
- Mean number of nocturia episodes at least 2 per night based on day sleep/bladder diary
- Epworth Sleepiness Scale Score of at least 10
- Clinical Global Impression of Sleepiness at least Moderate
- Age 18-90 years inclusive
Exclusion Criteria
- Medications affecting urinary or sleep-wake function other than therapy for OAB o or NP within 5 half-lives of baseline assessment
- Sleep disorders other than nocturia based on history and screening assessment
- Unstable medical or psychiatry conditions
- Medical or psychiatric conditions affecting sleep/wake or urologic function
- Apnea-Hypopnea Index (AHI) ≥ 15 on screening polysomnogram
- Periodic Leg Movement Arousal Index (PLMAI) ≥ 15 on screening polysomnogram
- History of substance abuse or dependence in the last year
- Regular consumption of over 800 mg of caffeine use
- Shift-work in the 3 months prior to or during the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Armodafinil First, Then Placebo Placebo During double-blind treatment subjects took armodafinil for 4 weeks before crossing over to placebo for 4 weeks. Pill is taken once daily, before 8 am. Armodafinil/placebo was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects. Placebo First, Then Armodafinil Placebo During double-blind treatment subjects took placebo for 4 weeks before crossing over to armodafinil for 4 weeks. Pill is taken once daily, before 8 am. Armodafinil/placebo was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects. Armodafinil First, Then Placebo Armodafinil During double-blind treatment subjects took armodafinil for 4 weeks before crossing over to placebo for 4 weeks. Pill is taken once daily, before 8 am. Armodafinil/placebo was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects. Placebo First, Then Armodafinil Armodafinil During double-blind treatment subjects took placebo for 4 weeks before crossing over to armodafinil for 4 weeks. Pill is taken once daily, before 8 am. Armodafinil/placebo was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
- Primary Outcome Measures
Name Time Method Change From Baseline in Epworth Sleepiness Scale [ESS] Baseline, Week 4 of each phase Epworth sleepiness scale (ESS) is measure of subjective sleepiness. Tendency to fall asleep in 8 situations. Total varies from zero to 24. A ESS of 10 or less is considered normal. Change is calculated as value at baseline minus value at week 4.
- Secondary Outcome Measures
Name Time Method Clinical Global Impressions, Change in Severity of Excessive Daytime Sleepiness (EDS) week 4, of each phase Scale consists of a 7 point likert rating scale where the anchors were 1= "normal"; 2= "borderline sleepiness"; 3= "mild sleepiness"; 4= "moderate sleepiness"; 5= "marked sleepiness"; 6= "severe sleepiness"; and 7= "among the most extremely sleepy individuals"
Mean Number of Nocturic Events (Episode of Urination Preceded and Followed by Sleep) week 4 of each phase. Nocturic Events is defined as an episode of urination preceded and followed by sleep. Measurements are for the preceding week
Mean Number of Naps/Day week 4 of each phase. measurements are for the preceding week
Mean Number of Minutes Napped Per Day Based on Sleep Diary week 4 of each phase. measurements are for the preceding week
Trial Locations
- Locations (1)
Duke University Medical Center
🇺🇸Durham, North Carolina, United States