Rationale, design, and methods of electroencephalography-based investigation of the effects of oral desmopressin on improving slow-wave sleep time in nocturnal polyuria patients (the DISTINCT study): protocol for a single-arm, open-label, single-assignment trial

Table 1 Primary and secondary endpoints of the DISTINCT Study

Primary endpoint	Secondary endpoints
Change in mean time of slow-wave sleep (N3 + N4) as evaluated by EEG at 28 days from baseline	1. Change is PSQI before and after desmopressin administration
	2. Change in nocturnal urinary frequency, the first nocturnal urinary volume, and the FUSP before and after desmopressin administration
	3. Change in sleep time, sleep effiency, and sleep quality as estimated by VAS before and after desmopressin administration
	4. Correlation between slow-wave sleep time (N3 + N4) and PSQI, VAS, FUSP, nocturnal urinay frequency at 28 days from baseline
	5. Change is delta power during the FUSP before and after desmopressin administration

N1–4 non-rapid eye movement sleep stage 1–4, EEG eletroecephalography, PSQI Pittsburgh sleep quality index, FUSP the first uninterrupted sleep period, VAS visual analogue scale

ISSN: 1471-2490