The aim of this study is to determine if suvorexant can help treat the severity of insomnia and improve metabolic health in midlife women who had both insomnia and indicators of metabolic syndrome.
The purpose of this research study is to investigate if suvorexant can help treat the severity of insomnia (a chronic sleep disorder) in midlife women and to learn whether improvement in insomnia symptoms is linked with improvement in metabolic health. This is a double-blind, randomized placebo-controlled crossover trial. Study procedures are conducted over a 14-week period (2-week screening period, 4-week treatment period \[Block 1\], 4-week washout, and 4-week treatment period \[Block 2\]). During each treatment block, participants take a daily pill - during one block, they take suvorexant and during the other block, they take a placebo (randomized to the order).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
31
20mg taken at bedtime for 4 weeks
placebo taken at bedtime for 4 weeks
Brigham and Women's Hospital
Boston, Massachusetts, United States
Change From Baseline in Insomnia Severity Index (ISI) Score at 4 Weeks
The Insomnia Severity Index (ISI) is a 7-item self-rated scale to assess the severity of insomnia symptoms. The total ISI score is the sum of all questions, with a total range from 0-28 with higher values indicating worse insomnia.
Time frame: baseline and end of each four-week intervention
Change From Baseline in Fasting Glucose Concentrations at 4 Weeks
Fasting glucose concentrations are determined from a blood sample collected at least 8 hours since last food intake.
Time frame: baseline and end of each four-week intervention
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