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Medication- Trazodone for Insomnia (Sleep-HD Trial)

Phase 3
Waitlist Available
Led By Raj Mehrotra, MD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 25
Awards & highlights

Sleep-HD Trial Summary

This trial will compare the effects of CBT-I versus treatment with a drug (trazodone vs placebo) on insomnia in patients with end-stage renal disease who are undergoing HD.

Eligible Conditions
  • Insomnia
  • Kidney Failure

Sleep-HD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 25
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 25 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Insomnia Severity Index (ISI) Long-term
Insomnia Severity Index (ISI) Short-term
Secondary outcome measures
Cumulative Weekly Use of Sedatives/Hypnotics - Long-term
Cumulative Weekly Use of Sedatives/Hypnotics - Short-term
Objective Measure of Sleep - Long-term
+19 more

Sleep-HD Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: Medication- TrazodoneActive Control1 Intervention
Trazodone (50-100 mg):
Group II: CBT-IActive Control1 Intervention
Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.
Group III: Medication- PlaceboPlacebo Group1 Intervention
Placebo (for trazodone)

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,314,466 Total Patients Enrolled
University of WashingtonLead Sponsor
1,741 Previous Clinical Trials
1,847,640 Total Patients Enrolled
2 Trials studying Insomnia
214 Patients Enrolled for Insomnia
Raj Mehrotra, MDPrincipal InvestigatorUniversity of Washington

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
BMC NephrologyJournal
Sleep-hd Trial: Short and Long-term Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis
Unruh, Mark, Daniel Cukor, Tessa Rue, Kashif Abad, Maria-Eleni Roumelioti, Susan M. McCurry, Patrick Heagerty, and Rajnish Mehrotra. 2020. “Sleep-hd Trial: Short and Long-term Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis”. BMC Nephrology. Springer Science and Business Media LLC. doi:10.1186/s12882-020-02107-x.
clinicaltrials.govStudy
Short and Long-Term Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis
Rajnish Mehrotra 2018. "Short and Long-Term Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03534284.
~19 spots leftby Apr 2025
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