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

Primary Purpose

Insomnia, Diabetes, Menopause

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Suvorexant
Placebo
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Brigham and Women's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

suvorexant

placebo

Arm Description

20mg taken at bedtime for 4 weeks

placebo taken at bedtime for 4 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 21, 2022
Last Updated
February 16, 2023
Sponsor
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05593653
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 6, 2023 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Diabetes, Menopause

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
61 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
suvorexant
Arm Type
Experimental
Arm Description
20mg taken at bedtime for 4 weeks
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo taken at bedtime for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Suvorexant
Other Intervention Name(s)
Belsomra
Intervention Description
20mg taken at bedtime for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo taken at bedtime for 4 weeks
Primary Outcome Measure Information:
Title
Insomnia Severity Index Score
Description
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 to 4 weeks
Secondary Outcome Measure Information:
Title
Fasting Plasma Glucose
Description
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.
Time Frame
baseline to 4 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aleta Wiley, MPH
Phone
617-525-9627
Email
awiley1@bwh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shadab Rahman, PhD MPH
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aleta Wiley, MPH

12. IPD Sharing Statement

Learn more about this trial

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

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