Efficacy of Suvorexant in the Treatment of Insomnia in Midlife Women With Pre-Diabetes

Diabetes Clinical Trial

Official title:

Treating Insomnia and Improving Glycemic Control in Midlife Women With Insomnia and Pre-diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05593653
• Other study ID #: 2022P000768
• Status: Recruiting
• Phase: Phase 4
• Start date: January 6, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: February 2023
• Source: Brigham and Women's Hospital
• Contact: Aleta Wiley, MPH
• Phone: 617-525-9627
• Email: awiley1[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 61
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Insomnia
• Menopause
• Prediabetic State
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• Suvorexant
20mg taken at bedtime for 4 weeks
• Placebo
placebo taken at bedtime for 4 weeks

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insomnia Severity Index Score	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.	baseline to 4 weeks
Secondary	Fasting Plasma Glucose	Fasting plasma glucose is determined from a blood sample collected at least 8 hours since last food intake. Range indications: 0-99 mg/dL is normal, 100-125 mg/dL is pre-diabetic, and 126 mg/dL+ indicates diabetes.	baseline to 4 weeks