Clinical trial NCT05593653: Efficacy of Suvorexant in the Treatment of Insomnia in Midlife Women With Pre-Diabetes
Official title: Treating Insomnia and Improving Glycemic Control in Midlife Women With Insomnia and Pre-diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Insomnia
Diabetes
Menopause
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2022-10-25
Enrollment: 61
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine if suvorexant can help treat the severity of insomnia in midlife women who are pre-diabetic.

Detailed description: 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 who are pre-diabetic, and to learn whether improvement in insomnia symptoms is linked with improvement in blood sugar levels. 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). Primary data collection includes blood draws, monitoring glucose and lipid levels, actigraphy, questionnaires, and daily diaries.

Eligibility criteria: Inclusion Criteria:

* Healthy women aged 40-65 years
* Postmenopausal or late perimenopausal
* Meets criteria for Insomnia Disorder
* Score on the Insomnia Severity Index (ISI) measure ≥15
* Subjective and sustained sleep disruption during screening
* Hot flashes present, including at night
* Pre-diabetic per guidelines from the American Diabetes Association

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 across time zones
* Excessive coffee or cigarette use
* Unwilling to limit alcohol, nicotine, and caffeine consumption during study

Primary outcomes:
measure: Insomnia Severity Index Score
timeFrame: baseline to 4 weeks
Secondary outcomes:
measure: Fasting Plasma Glucose
timeFrame: baseline to 4 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Shadab Rahman, PhD MPH
role: PRINCIPAL_INVESTIGATOR
References: