The purpose of this study is to compare the effectiveness and safety of suvorexant versus placebo on sleep pressure and circadian rhythm in hypertensives with insomnia.
The study consists of a 4-week run-in period and a 2-week treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
82
Suvorexant (20mg for 64 years or younger; 15mg for 65 years or older) once daily before bedtime.
Placebo once daily before bedtime.
Takahira Internal Medicine Clinic
Fukuoka, Japan
Yamasaki family clinic
Hyōgo, Japan
Yagi hospital
Tokyo, Japan
Change in Sleep Systolic Blood Pressure
To compare the efficacy of suvorexant versus placebo on sleep systolic blood pressure (SBP) by ambulatory blood pressure monitoring (ABPM). Change: sleep SBP value at 2 weeks minus value at baseline
Time frame: 2 weeks
Change in Morning Systolic Blood Pressure Variability
To compare the efficacy of suvorexant versus placebo on morning SBP variability by ABPM Variability: SD Change: value at 2 weeks minus value at baseline
Time frame: 2 weeks
Changes in the Total Sleep Time
Total sleep time was assessed using a sleep diary. Value at week 2 - Value at week 0
Time frame: 2 weeks
Changes in the Time to Sleep Onset
Time to sleep onset was assessed using a sleep diary. Value at week 2 - Value at week 0
Time frame: 2 weeks
Change in Nighttime SBP in Patients Achieved High Sleep Satisfaction
nighttime BPs are measured by ambulatory blood pressure monitoring. Sleep quality is measured by self-reported sleep diary (satisfaction level of sleep) at 2 weeks. Patients are divided by sleep satisfaction and compared nighttime SBP change (value at 2 weeks minus value at baseline).
Time frame: 2 weeks
Change in Urinary Albumin-to-creatinine Ratio (UACR)
Percentage change in UACR from baseline to 2 weeks
Time frame: 2 weeks
Change in Nighttime SBP in Patients Achieved Low Sleep Satisfaction
nighttime BPs are measured by ambulatory blood pressure monitoring. Sleep quality is measured by self-reported sleep diary (satisfaction level of sleep) at 2weeks. Patients are divided by sleep satisfaction and compared nighttime SBP change (value at 2 weeks minus value at baseline).
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Time frame: 2 weeks
Change in NT-proBNP
Percentage change in NT-proBNP from baseline to 2 weeks
Time frame: 2 weeks