Daytime Sleepiness, Nocturia
Conditions
Keywords
Nocturia, Daytime sleepiness
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.
Interventions
DRUGArmodafinil
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.
DRUGPlacebo
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.
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Receiving standard-of-care therapy for nocturia based on assessment by study physician 2. Evaluation by study physician indicates that the patient meets criteria for either overactive bladder diagnosis, or nocturnal polyuria diagnosis. 3. Mean number of nocturia episodes at least 2 per night based on day sleep/bladder diary 4. Epworth Sleepiness Scale Score of at least 10 5. Clinical Global Impression of Sleepiness at least Moderate 6. Age 18-90 years inclusive
Exclusion criteria
1. Medications affecting urinary or sleep-wake function other than therapy for OAB o or NP within 5 half-lives of baseline assessment 2. Sleep disorders other than nocturia based on history and screening assessment 3. Unstable medical or psychiatry conditions 4. Medical or psychiatric conditions affecting sleep/wake or urologic function 5. Apnea-Hypopnea Index (AHI) ≥ 15 on screening polysomnogram 6. Periodic Leg Movement Arousal Index (PLMAI) ≥ 15 on screening polysomnogram 7. History of substance abuse or dependence in the last year 8. Regular consumption of over 800 mg of caffeine use 9. Shift-work in the 3 months prior to or during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 |
Countries
United States
Participant flow
Recruitment details
Eighty-one individuals signed consent and were screened for entry into this study. Thirty of these subjects met the inclusion/exclusion criteria but only 28 subjects were randomized to the study. (2 subjects withdrew consent prior to randomization).
Participants by arm
| Arm | Count |
|---|---|
| All Randomized Participants | 28 |
| Total | 28 |
Baseline characteristics
| Characteristic | All Randomized Participants |
|---|---|
| Age, Customized Between 18 and 90 | 54.5 years STANDARD_DEVIATION 14.2 |
| Race/Ethnicity, Customized African American | 17 participants |
| Race/Ethnicity, Customized Asian | 1 participants |
| Race/Ethnicity, Customized Caucasian | 9 participants |
| Race/Ethnicity, Customized Mixed Race | 1 participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 11 / 28 | 10 / 28 |
| serious Total, serious adverse events | 0 / 28 | 0 / 28 |
Outcome results
Primary
Change From Baseline in Epworth Sleepiness Scale [ESS]
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.
Time frame: Baseline, Week 4 of each phase
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil | Change From Baseline in Epworth Sleepiness Scale [ESS] | 9.03 units on a scale | Standard Deviation 5.18 |
| Placebo | Change From Baseline in Epworth Sleepiness Scale [ESS] | 9.73 units on a scale | Standard Deviation 4.43 |
Secondary
Clinical Global Impressions, Change in Severity of Excessive Daytime Sleepiness (EDS)
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
Time frame: week 4, of each phase
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil | Clinical Global Impressions, Change in Severity of Excessive Daytime Sleepiness (EDS) | 2.58 units on a scale | Standard Deviation 1.03 |
| Placebo | Clinical Global Impressions, Change in Severity of Excessive Daytime Sleepiness (EDS) | 3.12 units on a scale | Standard Deviation 0.82 |
Secondary
Mean Number of Minutes Napped Per Day Based on Sleep Diary
measurements are for the preceding week
Time frame: week 4 of each phase.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil | Mean Number of Minutes Napped Per Day Based on Sleep Diary | 38.9 minutes napped per day | Standard Deviation 65.1 |
| Placebo | Mean Number of Minutes Napped Per Day Based on Sleep Diary | 40.0 minutes napped per day | Standard Deviation 61.3 |
Secondary
Mean Number of Naps/Day
measurements are for the preceding week
Time frame: week 4 of each phase.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil | Mean Number of Naps/Day | 0.48 naps per day | Standard Deviation 0.71 |
| Placebo | Mean Number of Naps/Day | 0.73 naps per day | Standard Deviation 1.2 |
Secondary
Mean Number of Nocturic Events (Episode of Urination Preceded and Followed by Sleep)
Nocturic Events is defined as an episode of urination preceded and followed by sleep. Measurements are for the preceding week
Time frame: week 4 of each phase.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Armodafinil | Mean Number of Nocturic Events (Episode of Urination Preceded and Followed by Sleep) | 1.6 Nocturic Events | Standard Deviation 1.1 |
| Placebo | Mean Number of Nocturic Events (Episode of Urination Preceded and Followed by Sleep) | 1.89 Nocturic Events | Standard Deviation 1.1 |