Sleep DisturbanceEarly Phase 1NCT07732725
Comparison Between the Effect of Two Different Doses of Oral Melatonin on Sleep Quality After Total Hip Arthroplasty
A Early Phase 1 study testing Melatonin 5 MG and Melatonin 10 MG in people with Sleep Disturbance, run by Benha University at 1 site in Egypt.
Trial summary
Considering the fact that melatonin was safely and effectively used in higher doses in multiple surgical conditions , the present study hypothesized that increasing melatonin dose in THA would have better benefits for patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sleep Disturbance
- What is being tested?
- Melatonin 5 MG and Melatonin 10 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Aug 2026to 4 Nov 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective unilateral total hip arthroplasty.
Who cannot join
- Revision arthroplasty
- documented sleep disorders requiring treatment,
- use of other sleep medications preoperatively
- known melatonin allergy or contraindication.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nourhan Amer, PhD contact
About this study
Official title: Comparison Between the Effect of Two Different Doses of Oral Melatonin on Sleep Quality After Total Hip Arthroplasty A Randomized Placebo-Controlled Double-Blind Trial
Considering the fact that melatonin was safely and effectively used in higher doses in multiple surgical conditions , the present study hypothesized that increasing melatonin dose in THA would have better benefits for patients.
Read the detailed description
Considering the fact that melatonin was safely and effectively used in higher doses in multiple surgical conditions, the present study hypothesized that increasing melatonin dose in THA would have better benefits for patients. Also, The present study aimed to assess the value of oral melatonin 5mg and 10mg given perioperatively on sleep quality in patients submitted to total hip arthroplasty.
- Conditions
- Sleep Disturbance
- Being tested
- Melatonin 5 MG, Melatonin 10 MG, 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 5 MGDrug
Also called Melatonin
Melatonin 5 mg and one placebo sugar tablet oral tablet, two hours preoperatively and for 14 nights postoperatively.
Melatonin 10 MGDrug
Also called Melatonin
Two melatonin 5 mg oral tablet, two hours preoperatively and for 14 nights postoperatively.
PlaceboOther
Two placebo sugar tablets, two hours preoperatively and for 14 nights postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| 5mg group | Experimental | Melatonin 5 mg and one placebo sugar tablet oral tablet, two hours preoperatively and for 14 nights postoperatively. Receives: Drug: Melatonin 5 MG |
| 10mg group | Experimental | Two melatonin 5 mg oral tablet, two hours preoperatively and for 14 nights postoperatively. Receives: Drug: Melatonin 10 MG |
| Control group | Placebo comparator | Two placebo sugar tablets, two hours preoperatively and for 14 nights postoperatively. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Quality
Patient-Reported Outcomes Measurement Information System (PROMIS) for sleep quality
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start4 Aug 2026 (estimated)
- Primary completion4 Nov 2026 (estimated)
- Study completion4 Nov 2026 (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.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nourhan Elsayed Mohamed Amer, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07732725
- Sponsor's protocol ID
- RC.1.5.2026
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 29 Jul 2026
- 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 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Effect of Two Different Doses of Oral Melatonin on Sleep Quality After Total Hip Arthroplasty A Randomized Placebo-Controlled Double-Blind Trial
- ClinicalTrials.gov ID
- NCT07732725
- Acronym / sponsor ID
- RC.1.5.2026
- Conditions
- Sleep Disturbance
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 4 Aug 2026 (estimated)
- Primary completion
- 4 Nov 2026 (estimated)
- Study completion
- 4 Nov 2026 (estimated)
- First posted
- 29 Jul 2026 (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.
Considering the fact that melatonin was safely and effectively used in higher doses in multiple surgical conditions , the present study hypothesized that increasing melatonin dose in THA would have better benefits for patients.
Detailed description
Considering the fact that melatonin was safely and effectively used in higher doses in multiple surgical conditions, the present study hypothesized that increasing melatonin dose in THA would have better benefits for patients. Also, The present study aimed to assess the value of oral melatonin 5mg and 10mg given perioperatively on sleep quality in patients submitted to total hip arthroplasty.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 5mg group | Experimental | Drug: Melatonin 5 MGMelatonin 5 mg and one placebo sugar tablet oral tablet, two hours preoperatively and for 14 nights postoperatively. |
| 10mg group | Experimental | Drug: Melatonin 10 MGTwo melatonin 5 mg oral tablet, two hours preoperatively and for 14 nights postoperatively. |
| Control group | Placebo comparator | Other: PlaceboTwo placebo sugar tablets, two hours preoperatively and for 14 nights postoperatively. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective unilateral total hip arthroplasty.
Key exclusion criteria (4 listed)
- Revision arthroplasty
- documented sleep disorders requiring treatment,
- use of other sleep medications preoperatively
- known melatonin allergy or contraindication.
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 5 MGAlso: MelatoninMelatonin 5 mg and one placebo sugar tablet oral tablet, two hours preoperatively and for 14 nights postoperatively. | Drug | 5mg group |
| Melatonin 10 MGAlso: MelatoninTwo melatonin 5 mg oral tablet, two hours preoperatively and for 14 nights postoperatively. | Drug | 10mg group |
| PlaceboTwo placebo sugar tablets, two hours preoperatively and for 14 nights postoperatively. | Other | Control group |
Primary outcome
Sleep Quality
Time frame: 14 days
Patient-Reported Outcomes Measurement Information System (PROMIS) for sleep quality
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
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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.
Nourhan Amer, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Melatonin 5 MG and Melatonin 10 MG in people with Sleep Disturbance, run by Benha University at 1 site in Egypt.
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 1 inclusion and 4 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: opening soon, as of the sponsor's last update on 29 Jul 2026. 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 Egypt. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nourhan Amer, PhD (+20 11 11337700), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Quality (time frame: 14 days). 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 29 Jul 2026.