Sleep DisturbanceNCT04278677
Sleep Quality and Pain Medication Use Following Arthroscopic Rotator Cuff Repair
A study testing melatonin in people with Sleep Disturbance, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
The purpose of this study is to investigate if oral melatonin reduces postoperative sleep 18 disturbances and narcotics use. We will enroll patients undergoing primary arthroscopic rotator 19 cuff repair (ARCR) at the Rothman Institute. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Disturbance
- What is being tested?
- melatonin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2020to Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who undergo primary ARCR
- Patient willing and able to complete postoperative surveys
Who cannot join
- Daily melatonin use for > 1 week during the last 3 months
- Irreparable tears
- Revision rotator cuff repairs
- Severe glenohumeral arthritis
- Concurrent adhesive capsulitis
- Age less than 18
Show all 16Show fewer
- Pregnancy
- History of substance abuse (drug or alcohol)
- Workman's comp patient or patient has current litigation pending
- Allergy to melatonin
- History of delirium/psychiatric/depression/ on antidepressants
- History of insomnia/ on sleep aid medication
- Use of prescription sedatives
- use of Zelboraf (vemurafenib)
- Use of all blood thinning medications besides aspirin (warfarin, plavix, lovenox, etc.)
- Sleep apnea
Trial locations and contacts
1 site in 1 country.
United States1 site
Rothman Orthopaedics at Egg Harbor Township
Egg Harbor, New Jersey, 08234
About this study
The purpose of this study is to investigate if oral melatonin reduces postoperative sleep 18 disturbances and narcotics use. We will enroll patients undergoing primary arthroscopic rotator 19 cuff repair (ARCR) at the Rothman Institute.
- Conditions
- Sleep Disturbance
- Being tested
- melatonin
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
melatoninDietary supplement
Melatonin capsules to be taken for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Melatonin supplementation | Active comparator | 5mg melatonin tablets to be taken for 6 weeks Receives: Dietary Supplement: melatonin |
| No supplementation | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburg Sleep Quality Index (PSQI)
PSQI is a validated outcome measure for sleep quality
Measured: 6 weeks post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study startMar 2020 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Crossover
- Model description
- This is a provider-crossover study design.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04278677
- Sponsor's protocol ID
- 2020 TJ 02
- Status last verified
- Feb 2020
- First submitted
- 18 Feb 2020
- Last updated
- 20 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Perez AR, Destine H, Patel NK, Campbell RE, Muchintala R, Hall AT, Pepe MD, Tucker BS, Tjoumakaris FP. Effects of Melatonin on Sleep Quality and Patient-Reported Outcomes After Arthroscopic Rotator Cuff Surgery: A Prospective Randomized Controlled Trial. Am J Sports Med. 2024 Oct;52(12):3075-3083. doi: 10.1177/03635465241272076. Epub 2024 Sep 15.
PubMed 39279257
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Quality and Pain Medication Use Following Arthroscopic Rotator Cuff Repair
- ClinicalTrials.gov ID
- NCT04278677
- Acronym / sponsor ID
- 2020 TJ 02
- Conditions
- Sleep Disturbance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- Mar 2020 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 20 Feb 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 investigate if oral melatonin reduces postoperative sleep 18 disturbances and narcotics use. We will enroll patients undergoing primary arthroscopic rotator 19 cuff repair (ARCR) at the Rothman Institute.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a provider-crossover study design.
| Arm | Type | Receives |
|---|---|---|
| Melatonin supplementation | Active comparator | Dietary Supplement: melatonin5mg melatonin tablets to be taken for 6 weeks |
| No supplementation | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who undergo primary ARCR
- Patient willing and able to complete postoperative surveys
Key exclusion criteria (16 listed)
- Daily melatonin use for > 1 week during the last 3 months
- Irreparable tears
- Revision rotator cuff repairs
- Severe glenohumeral arthritis
- Concurrent adhesive capsulitis
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 |
|---|---|---|
| melatoninMelatonin capsules to be taken for 6 weeks | Dietary supplement | Melatonin supplementation |
Primary outcome
Pittsburg Sleep Quality Index (PSQI)
Time frame: 6 weeks post-surgery
PSQI is a validated outcome measure for sleep quality
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Derived from this study: PubMed 39279257Perez AR, Destine H, Patel NK, Campbell RE, Muchintala R, Hall AT, Pepe MD, Tucker BS, Tjoumakaris FP. Effects of Melatonin on Sleep Quality and Patient-Reported Outcomes After Arthroscopic Rotator Cuff Surgery: A Prospective Randomized Controlled Trial. Am J Sports Med. 2024 Oct;52(12):3075-3083. doi: 10.1177/03635465241272076. Epub 2024 Sep 15.
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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 in people with Sleep Disturbance, 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 16 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 20 Feb 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. 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?
Pittsburg Sleep Quality Index (PSQI) (time frame: 6 weeks post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04278677, which also lists 1 linked publication.
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 20 Feb 2020.