Sleep DisturbanceNCT04590742
Randomized Trial Investigating Melatonin Supplementation vs Placebo on Sleep Disturbance Following Total Joint Arthroplasty
A study testing melatonin 6mg in people with Sleep Disturbance and Total Joint Arthroplasty, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
The purpose of this study is to determine whether melatonin when used as a supplement after surgery improves sleep following total joint arthroplasty Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disturbance, Total Joint Arthroplasty
- What is being tested?
- melatonin 6mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2018to 30 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who undergo unilateral primary total joint arthroplasty
- Patient willing and able to complete postoperative surveys
Who cannot join
- Patients who undergo revision total joint arthroplasty
- Patients who undergo bilateral total joint arthroplasty
- Patients currently taking melatonin supplementation
- Patient has history of substance abuse (drug or alcohol)
- Patient is a workman's comp patient or patient has current litigation pending
- Patient has an allergy to melatonin
Show all 13Show fewer
- Patient has a history of delirium/psychiatric/depression/on antidepressants
- Patient has a history of insomnia/ on sleep aid medication
- Anyone on warfarin
- Sleep apnea
- Patient discharged to SNF or rehab
- Patients who have inflammatory conditions
- Shift work or night work
Trial locations and contacts
1 site in 1 country.
United States1 site
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107
About this study
The purpose of this study is to determine whether melatonin when used as a supplement after surgery improves sleep following total joint arthroplasty
- Conditions
- Sleep Disturbance, Total Joint Arthroplasty
- Being tested
- melatonin 6mg, Placebo
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
melatonin 6mgDrug
6 weeks of melatonin (6mg) given to patient
PlaceboDrug
Patient given 6 weeks of placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Placebo comparator | Placebo Tablet Receives: Drug: Placebo |
| Group 2 | Active comparator | Melatonin (6mg) Receives: Drug: melatonin 6mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Sleep Quality
Patients quality of sleep will be analyzed by having them answer a sleep quality index (PSQI) questionnaires
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start27 Feb 2018
- Primary completion30 Nov 2021 (estimated)
- Study completion30 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04590742
- Sponsor's protocol ID
- JJP17D.511
- Status last verified
- Oct 2020
- First submitted
- 12 Oct 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Investigating Melatonin Supplementation vs Placebo on Sleep Disturbance Following Total Joint Arthroplasty
- ClinicalTrials.gov ID
- NCT04590742
- Acronym / sponsor ID
- JJP17D.511
- Conditions
- Sleep Disturbance, Total Joint Arthroplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- 27 Feb 2018 (actual)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 30 Nov 2021 (estimated)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether melatonin when used as a supplement after surgery improves sleep following total joint arthroplasty
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Placebo comparator | Drug: PlaceboPlacebo Tablet |
| Group 2 | Active comparator | Drug: melatonin 6mgMelatonin (6mg) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who undergo unilateral primary total joint arthroplasty
- Patient willing and able to complete postoperative surveys
Key exclusion criteria (13 listed)
- Patients who undergo revision total joint arthroplasty
- Patients who undergo bilateral total joint arthroplasty
- Patients currently taking melatonin supplementation
- Patient has history of substance abuse (drug or alcohol)
- Patient is a workman's comp patient or patient has current litigation pending
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| melatonin 6mg6 weeks of melatonin (6mg) given to patient | Drug | Group 2 |
| PlaceboPatient given 6 weeks of placebo tablet | Drug | Group 1 |
Primary outcome
Patient Sleep Quality
Time frame: 6 weeks
Patients quality of sleep will be analyzed by having them answer a sleep quality index (PSQI) questionnaires
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing melatonin 6mg in people with Sleep Disturbance and Total Joint Arthroplasty, run by Rothman Institute Orthopaedics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Sleep Quality (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.