Treating Insomnia and Improving Metabolic Health in Midlife Women With Insomnia (NCT05593653) | Clinical Trial Compass
CompletedPhase 4
Treating Insomnia and Improving Metabolic Health in Midlife Women With Insomnia
United States31 participantsStarted 2023-01-06
Plain-language summary
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.
Who can participate
Age range40 Years – 65 Years
SexFEMALE
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Inclusion Criteria:
* Healthy women aged 40-65 years
* Late perimenopausal or postmenopausal
* Meets criteria for Insomnia Disorder
* Elevated score on the Insomnia Severity Index (ISI) consistent with clinical insomnia
* Subjective and sustained sleep disruption during screening
* Hot flashes present, including at night
* Pre-diabetic per American Diabetes Association guidelines or have abnormal levels of one or more atherosclerotic cardiovascular disease risk factors per American Heart Association-defined metabolic syndrome
Exclusion Criteria:
* Diagnosis of other primary sleep disorders
* Shift worker
* Frequent use of hypnotic medications
* Unwillingness to refrain from taking any sleep medications during the study period
* Current major depressive episode
* Suicidal ideation
* Lifetime history of bipolar disorder, psychosis, or other serious mental health problem
* Current alcohol/substance use disorder
* Current or prior diagnosis of diabetes mellitus
* Use of an insulin sensitizer or a pharmacologic treatment for pre-diabetes
* Extreme obesity
* Current use of systemic hormonal therapies
* Renal or hepatic disease
* Pregnancy or breastfeeding
* Recent malignancy
* Recent surgery
* Neurological disorder or cardiovascular disease raising safety concerns
* Medical instability considered to interfere with study procedures
* Concomitant medications with drug interaction or co-administration concerns
* Contraindications or allergic responses to suvorexant
* Recent travel …
What they're measuring
1
Change From Baseline in Insomnia Severity Index (ISI) Score at 4 Weeks
Timeframe: baseline and end of each four-week intervention