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NCT07598734 · ClinicalTrials.gov registry record · Phase 4
Doxepin Alone or Combined With Ramelteon Versus Placebo for Improving Sleep Quality After Primary Total Knee Arthroplasty
A Phase 4 study, sponsored by University of Washington.
- Not yet
- Registry status
- Phase 4
- Development phase
- 129
- Enrollment target
NCT07598734: Clinical Trial Phase 4 study, sponsored by University of Washington.
NCT07598734 is a Phase 4 study that has not yet begun recruiting, run by University of Washington. The registered enrollment target is 129 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07598734, a Phase 4 study, has not yet begun recruiting, sponsored by University of Washington.
- NOT YET RECRUITING
- Registry status
- Phase 4
- Development phase
- 129 participants
- Enrollment target
Study Summary
Many patients experience poor sleep during recovery after total knee arthroplasty (TKA). Disturbed sleep can last weeks to months and may worsen pain, slow healing, and reduce overall quality of life. Few safe, effective, evidence-based options exist to improve sleep during this recovery period. This study aims to determine whether the medications doxepin, either alone or in combination with ramelteon, can improve sleep quality during early recovery after TKA. The investigators will also evaluate whether improved sleep leads to better pain control, knee function, and overall quality of life.
Primary Outcome
Insomnia Severity Index (ISI) The Insomnia Severity Index is a 7-item self-reported questionnaire assessing the nature, severity, and impact of insomnia. * Score range: 0 to 28 * Interpretation: Higher scores indicate worse insomnia severity Score categories: * 0-7: No clinically significant insomnia * 8-14: Subthreshold insomnia * 15-21: Clinical insomnia (moderate severity) * 22-28: Clinical insomnia (severe)
Interventions
- DRUG Placebo Tablets
- DRUG Doxepin 6 mg
- DRUG Ramelteon 8 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 129 participants |
| Start Date | 2026-06 |
| Est. Completion | 2028-06 |
| Phase | Phase 4 |
What is known before NCT07598734 opens enrollment
NCT07598734 is an interventional study that assigns participants to a tested intervention. The registered 129 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo Tablets is the first listed.
NCT07598734 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07598734 about?
NCT07598734 is a clinical study titled "Doxepin Alone or Combined With Ramelteon Versus Placebo for Improving Sleep Quality After Primary Total Knee Arthroplasty". Many patients experience poor sleep during recovery after total knee arthroplasty (TKA). Disturbed sleep can last weeks to months and may worsen pain, slow healing, and reduce overall quality of life. Few safe, effective, evidence-based options exist to improve sleep during this recovery period. Thi...
What is the current status of trial NCT07598734?
This trial is currently not yet recruiting. It is a Phase 4 study. The enrollment target is 129 participants. The study started on 2026-06. Estimated completion is 2028-06.
What interventions are being tested in trial NCT07598734?
The interventions under investigation include: Placebo Tablets (DRUG), Doxepin 6 mg (DRUG), Ramelteon 8 mg (DRUG).
Who is sponsoring clinical trial NCT07598734?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07598734's enrollment target sits among peer trials
129 631st of 2000 higher than 1,367 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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