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Electroencephalography-based investigation of the effects of oral desmopressin on improving slow-wave sleep time in nocturnal polyuria patients (The DISTINCT study)

Electroencephalography-based investigation of the effects of oral desmopressin on improving slow-wave sleep time in nocturnal polyuria patients (The DISTINCT study)

Torimoto Kazumasa

Nara Medical University Hospital

840 Shijo-cho, Kashihara, Nara

torimoto@naramed-u.ac.jp

Torimoto Kazumasa

Nara Medical University Hospital

840 Shijo-cho, Kashihara, Nara

+81-744-22-3051

torimoto@naramed-u.ac.jp

Complete

Dec. 09, 2019

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1 Nocturnal urinary frequency = and >2 and Nocturnal polyuria index (nocturnal urinary volume/24 hours urinary volume) = and >0.33
2 Hours of undisturbed sleep before registration = and <2.5 hours
3 Concentration of serum sodium = and >135 mEq/L
4 Creatinine clearance or eGFR (estimate glomerular filtration rate) = and >50 mL/min/1.73m^2

1 Hyponatremia or the history (Concentration of serum sodium <135 mEq/L)
2 Habitual or Psychogenic polydipsia
3 Heart failure or the history or suspected heart failure
4 Fluid retention that requires diuretic treatment or the history
5 Antidiuretic hormone incompatible secretion syndrome
6 Moderate or severe renal failure (Creatinine clearance or eGFR <50 mL/min/1.73m^2)
7 Hypersensitivity to desmopressin or the history
8 During or scheduled administration of thiazides, thiazide-like diuretics, loop diuretics
9 During or scheduled administration of corticosteroids
10 Carciac pacemaker implantation
11 Judged to be inappropriate by the principal Investigator or subinvestigators

Male

Nocturia due to nocturnal polyuria

Oral administration of desmopressin OD tablet 50 microgram once daily before bedtime

nocturia, nocturnal polyuria

desmopressin

D053158

D000284

Change of slow wave sleep time (N3 + N4) using a portable electroencephalograph before and after desmopressin administration

- Change of Pittsbllrgh Sleep Quality lndex before and after desmopressin administration
- Change of nocturnal urinary frequency, the first nocturnal urinary volume, and hours of undisturbed sleep before and after desmopressin administration
- Change of sleep time, sleep effiency, sleep quality estimated by VAS before and after desmopressin administration
- Correlation between nocturnal urinay frequency and slow wave sleep time (N3 + N4)
- Change of delta power from falling asleep to the first urination before and after desmopressin administration

+81-744-29-8835

No

none