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

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05593653
Collaborator
(none)
61
Enrollment
2
Arms
22
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
61 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Treating Insomnia and Improving Glycemic Control in Midlife Women With Insomnia and Pre-diabetes
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Sep 30, 2024
Anticipated Study Completion Date :
Sep 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: suvorexant

20mg taken at bedtime for 4 weeks

Drug: Suvorexant
20mg taken at bedtime for 4 weeks
Other Names:
  • Belsomra

    		•
    Placebo Comparator: placebo

    placebo taken at bedtime for 4 weeks

    Drug: Placebo
    placebo taken at bedtime for 4 weeks

    Outcome Measures

    Primary Outcome Measures

    1. Insomnia Severity Index Score [baseline to 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.

    Secondary Outcome Measures

    1. Fasting Plasma Glucose [baseline to 4 weeks]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 65 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Brigham and Women's Hospital

    Investigators

    • Principal Investigator: Shadab Rahman, PhD MPH, Brigham and Women's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shadab A Rahman, Study Principal Investigator, Brigham and Women's Hospital
    ClinicalTrials.gov Identifier:
    NCT05593653
    Other Study ID Numbers:
    • 2022P000768
    First Posted:
    Oct 25, 2022
    Last Update Posted:
    Oct 25, 2022
    Last Verified:
    Oct 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Sleep Initiation and Maintenance Disorders
    Diabetes Mellitus
    Prediabetic State
    Suvorexant

    Study Results

    No Results Posted as of Oct 25, 2022