Skip to main content
OpenTrials
Completed

NCT Number: NCT02151253

Cross-over Study of Armodafinil Treatment of Daytime Sleepiness Associated With Treated Nocturia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Nocturia Daytime Sleepiness Disorders of Excessive Somnolence Dyssomnias Lower Urinary Tract Symptoms Mental Disorders Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Wake Disorders Urological Manifestations

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Armodafinil

Drug

Armodafinil 50 - 250 mg pills Subjects took armodafinil once daily, before 8 am. Armodafinil 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

Drug

Subject given placebo tablets to match Armodafinil pills. Subjects took placebo once daily, before 8 am. Placebo was initiated as 1 tablet and titrated to 3 tablets 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 5 tablets or reduced back to 1 tablet 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 outcomes

  1. Change From Baseline in Epworth Sleepiness Scale [ESS]

    Time frame: 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 outcomes

  1. Clinical Global Impressions, Change in Severity of Excessive Daytime Sleepiness (EDS)

    Time frame: 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"

  2. Mean Number of Naps/Day

    Time frame: week 4 of each phase.

    measurements are for the preceding week

  3. Mean Number of Minutes Napped Per Day Based on Sleep Diary

    Time frame: week 4 of each phase.

    measurements are for the preceding week

  4. Mean Number of Nocturic Events (Episode of Urination Preceded and Followed by Sleep)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

A Double-Blind, Placebo-Controlled, Cross-over Study of Armodafinil Treatment of Daytime Sleepiness Associated With Treated Nocturia

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
May 30, 2014
Registry last updated
Mar 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.