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NCT03534284 · ClinicalTrials.gov registry record · Phase 3
Short and Long-Term Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis
A Phase 3 study of Insomnia and End Stage Renal Disease, sponsored by University of Washington.
- Completed
- Registry status
- Phase 3
- Development phase
- 126
- Enrollment target
- 1
- Study location
NCT03534284: Completed Phase 3 study of Insomnia and End Stage Renal Disease, sponsored by University of Washington.
NCT03534284 is a Phase 3 study of Insomnia and End Stage Renal Disease that has completed, run by University of Washington. The registered enrollment target is 126 participants, below the 169-participant average among 151 other Insomnia trials with a reported enrollment target (25% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03534284, a Phase 3 study of Insomnia and End Stage Renal Disease, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 126 participants
- Enrollment target
- 1
- Study location
Study Summary
Insomnia is a common and distressing symptom for patients on hemodialysis (HD), and there is evidence for a much larger impact on the health of patients. Chronic insomnia is disrupted sleep that occurs at least three nights per week and lasts at least three months. The SLEEP-HD study is a randomized open-label clinical trial to compare two types of treatment for insomnia in participants who have end-stage renal disease on HD, and who have been diagnosed with chronic insomnia. The two types of treatment involved in the study are Cognitive Behavioral Therapy for Insomnia (CBT-I) or treatment with a drug (trazodone vs placebo). 126 participants will be enrolled who are undergoing HD in two study locations (Seattle, Washington and Albuquerque, New Mexico).
Primary Outcome
summary score obtained from the ISI, measuring insomnia, range from 0 to 28. Higher score indicates greater insomnia, at Week 7 describing the short-term effect of the intervention
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Trazodone
- BEHAVIORAL Cognitive Behavioral Therapy for Insomnia
Study Locations (1)
Washington
- Northwest Kidney Centers - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2018-09-19 |
| Est. Completion | 2022-11-17 |
| Phase | Phase 3 |
What the finished NCT03534284 record still lists
NCT03534284 is an interventional study that assigns participants to a tested intervention. The registered 126 participants enrollment target is mid-sized for trials with a published cap, below the 169-participant average among 151 other Insomnia trials with a reported enrollment target (25% lower).
The record links to 2 conditions, with Insomnia appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT03534284 reports a single indexed study location in Washington.
Frequently Asked Questions
What is clinical trial NCT03534284 about?
NCT03534284 is a clinical study titled "Short and Long-Term Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis". Insomnia is a common and distressing symptom for patients on hemodialysis (HD), and there is evidence for a much larger impact on the health of patients. Chronic insomnia is disrupted sleep that occurs at least three nights per week and lasts at least three months. The SLEEP-HD study is a randomize...
What is the current status of trial NCT03534284?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 126 participants. The study started on 2018-09-19. Estimated completion is 2022-11-17.
What conditions does trial NCT03534284 study?
This clinical trial studies the following conditions: Insomnia, End Stage Renal Disease.
What interventions are being tested in trial NCT03534284?
The interventions under investigation include: Placebo (DRUG), Trazodone (DRUG), Cognitive Behavioral Therapy for Insomnia (BEHAVIORAL).
Who is sponsoring clinical trial NCT03534284?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03534284 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Insomnia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03534284's enrollment target sits among peer trials
126 55th of 151 higher than 97 of 151 other Insomnia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Insomnia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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