RECRUITING

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

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Conditions

InsomniaDiabetesMenopause

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2023-01-06
Study Completion:2024-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05593653

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 65 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Healthy women aged 40-65 years
  2. * Postmenopausal or late perimenopausal
  3. * Meets criteria for Insomnia Disorder
  4. * Score on the Insomnia Severity Index (ISI) measure ≥15
  5. * Subjective and sustained sleep disruption during screening
  6. * Hot flashes present, including at night
  7. * Pre-diabetic per guidelines from the American Diabetes Association
  1. * Diagnosis of other primary sleep disorders
  2. * Shift worker
  3. * Frequent use of hypnotic medications
  4. * Unwillingness to refrain from taking any sleep medications during the study period
  5. * Current major depressive episode
  6. * Suicidal ideation
  7. * Lifetime history of bipolar disorder, psychosis, or other serious mental health problem
  8. * Current alcohol/substance use disorder
  9. * Current or prior diagnosis of diabetes mellitus
  10. * Use of an insulin sensitizer or a pharmacologic treatment for pre-diabetes
  11. * Extreme obesity
  12. * Current use of systemic hormonal therapies
  13. * Renal or hepatic disease
  14. * Pregnancy or breastfeeding
  15. * Recent malignancy
  16. * Recent surgery
  17. * Neurological disorder or cardiovascular disease raising safety concerns
  18. * Medical instability considered to interfere with study procedures
  19. * Concomitant medications with drug interaction or co-administration concerns
  20. * Contraindications or allergic responses to suvorexant
  21. * Recent travel across time zones
  22. * Excessive coffee or cigarette use
  23. * Unwilling to limit alcohol, nicotine, and caffeine consumption during study

Contacts and Locations

Study Contact

Aleta Wiley, MPH
CONTACT
617-525-9627
awiley1@bwh.harvard.edu

Principal Investigator

Shadab Rahman, PhD MPH
PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital

Study Locations (Sites)

Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

  • Shadab Rahman, PhD MPH, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-06
Study Completion Date2024-09-30

Study Record Updates

Study Start Date2023-01-06
Study Completion Date2024-09-30

Terms related to this study

Additional Relevant MeSH Terms

  • Insomnia
  • Diabetes
  • Menopause