Electroencephalography-based investigation of the effects of oral desmopressin on improving slow-wave sleep time in nocturnal polyuria patients

JRCT ID: jRCTs051190080

Registered date:09/12/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Nocturia due to nocturnal polyuria
• Date of first enrollment: 07/01/2020
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Oral administration of desmopressin OD tablet 50 microgram once daily before bedtime

Outcome(s)

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

Secondary Outcome

- 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

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: Not applicable
• Gender: Male

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Torimoto Kazumasa
• Source(s) of Monetary Support: Ferring Pharmaceuticals Co.,Ltd.