Last reviewed · How we verify
NCT05332717
TKA Melatonin and Sleep Quality
NA trial testing Melatonin 5 mg in Arthroplasty in 176 participants. Completed in 30 April 2022.
31 January 2022
Quick facts
| Lead sponsor | Hospital for Special Surgery, New York |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | supportive care |
| Enrollment | 176 |
| Start date | 10 January 2022 |
| Primary completion | 31 January 2022 |
| Estimated completion | 30 April 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Melatonin 5 mg — full drug profile →
- Placebo (Vitamin C)
Conditions studied
- Arthroplasty — all drugs for Arthroplasty →
- Replacement — all drugs for Replacement →
- Knee — all drugs for Knee →
- Sleep Initiation and Maintenance Disorders — all drugs for Sleep Initiation and Maintenance Disorders →
Sponsor
Hospital for Special Surgery, New York
Who can join
18 and older, any sex, with Arthroplasty or Replacement. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This randomized controlled trial (RCT) will compare the effects of melatonin vs. placebo in patients undergoing primary total knee arthroplasty (TKA). This RCT aims to study the effects melatonin has on sleep quality after TKA. Patients will be blinded to their respective groups and will be instructed to take either 5mg melatonin or a placebo pill (Vitamin C) for 6 weeks postoperative. Sleep quality surveys will be administered preoperatively and post-operative week 6, 90-days and 1 year. Poor sleep quality is a common issue faced by patients undergoing TKA. The goal of this study is see if melatonin can improve postoperative sleep quality, and if so, does improved sleep quality correlate to improvements in other postoperative outcomes.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05332717
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Melatonin 5 mg
Trials testing the same drug.
- NCT07380568 — Melatonin on Post Operative Pain After CS · NA · recruiting
- NCT04959825 — The Role of Preoperative Melatonin in Reducing the Inhaled Isoflurane Requirements in Open Nephrectomy · EARLY_PHASE1 · completed
- NCT04795336 — Melatonin Use After Primary Total Joint Arthroplasty · Phase 1 · completed
- NCT04233112 — Melatonin and Osteogenic Loading on Osteopenia · EARLY_PHASE1 · active not recruiting
- NCT03708341 — Exogenous Melatonin in Intensive Care Unit Chronodisruption · Phase 3 · unknown
Other recruiting trials for Arthroplasty
Currently open trials in the same condition.
- NCT07425457 — Cryoneurolysis Prior to Total Knee Arthroplasty (CRYO-TKA Trial) · NA · recruiting
- NCT06323980 — INHANCE Stemless Reverse Shoulder IDE · NA · recruiting
- NCT04848896 — Study to Evaluate the Safety and Effectiveness of the REAL INTELLIGENCE™ CORI™ in Total Knee Arthroplasty (TKA) Procedur · NA · recruiting
- NCT04849884 — To Evaluate the Performance of the CORI™ KNEE TENSIONER as an Accessory to the CORI™ Surgical System. · NA · active not recruiting
- NCT05190666 — Healthy Living After Knee Replacement · NA · active not recruiting
Other Hospital for Special Surgery, New York trials
Trials by the same sponsor.
- NCT07226700 — Suzetrigine in Total Hip Arthroplasty · Phase 3 · recruiting
- NCT06567873 — Gastric Ultrasound Assessment for Patients Taking Cannabis · completed
- NCT07217964 — Natural Matrix Protein · enrolling by invitation
- NCT06798493 — CSS-SR Validation Study · enrolling by invitation
- NCT06180486 — Mindfulness Meditation Intervention Study · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05332717 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hospital for Special Surgery, New York
- Last refreshed: 14 September 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05332717.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing