Sleep ProblemsPhase 3NCT00388661
Melatonin and Quality of Life in Dialysis Patients
A Phase 3 study testing Melatonin tablet 3 mg once daily in people with Sleep Problems and Haemodialysis, run by Meander Medical Center at 2 sites in Netherlands.
Trial summary
Sleep problems can lead to a bad quality of life and a raise of morbidity, also in dialysis patients. Sleep problems can be caused by a disturbance of circadian rhythms in our body. For a good regulation of these circadian rhythms a uniform external synchronisation is necessary. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Sleep Problems, Haemodialysis
- What is being tested?
- Melatonin tablet 3 mg once daily
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 2 sitesNetherlands
- Study dates
- Apr 2007to Dec 2009
- Phase
- Phase 3
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed Consent
- Man/Women between 18 and 85 years
- Understanding and knowledge of the dutch language
- End Stage Renal Disease, stable chronic hemodialysis > 3 months
- SpKt/V(total) > 1,2 pro dialysis
- Validated actometer shows that sleep efficiency < 90% or sleep latency > 15 minutes or fragmentation index > 25 points
Who cannot join
- Known major illness, which interferes with patient's participation in the study according to the investigator)or which results in a probable patient's survival of less than 1 year.
- Instable angina pectoris, heart failure NYHA class IV
- Pregnancy
- Current use of melatonin of known allergy of melatonin
- Participation in other medication/drug research within a month before inclusion
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Meander Medical Center
Amersfoort, 3800 BM
Kennemer Gasthuis
Haarlem, 2035 RC
About this study
Official title: Double Blind Placebo-controlled Study on the Efficacy of Melatonin on Sleep, Resulting in an Improved Quality of Life in Hemodialysis Patients
Sleep problems can lead to a bad quality of life and a raise of morbidity, also in dialysis patients. Sleep problems can be caused by a disturbance of circadian rhythms in our body. For a good regulation of these circadian rhythms a uniform external synchronisation is necessary. This is the synchronisation of the biological clock of our body by light and other influences. In case of a disturbance of the external synchronisation, due to for example naps during the day or wake periods at night, internal rhythms can be unlinked. As a result a weakened melatonin rhythm and a problematic sleep-wake cycle can be observed. Most dialysis patients have sleep problems. Their sleep latency is prolonged. They often take a nap during the day and their sleep efficiency is poor. There has only been one study on the melatonin rhythm of dialysis patients. The conclusion of this study was that the melatonin rhythm of dialysis patients is weakened and disturbed, probably caused by renal insufficiency. In this study no link was made between melatonin rhythm and the nature and severity of possible sleep problems. In different studies with non-dialysis patients and a disturbed melatonin rhythm, exogenous melatonin at the right time leads to a recovery of the normal rhythm and the normal biological clock and a better quality of life.
The aim is to improve quality of life of hemodialysis patients with a placebo-controlled study with melatonin to investigate if exogenous melatonin can improve sleep problems and on the longer term improve quality of life (and secondary morbidity) of dialysis patients.
Read the detailed description
Objective of the study:
Does melatonin by improving sleep parameters improve quality of life of hemodialysis patients?
Study design:
Placebo-controlled, double-blind, randomized trial
Study population:
hemodialysis patients
Intervention:
melatonin 3 mg once daily (or placebo)
Primary study parameters/outcome of the study:
- improvement of vitality (dimension quality of life) by 15 points (RAND SF 36)
- improvement general health by 15 points (dimension quality of life, RAND SF 36)
Secondary study parameters/outcome of the study:
- Change in biochemical parameters
- Change in ProBNP
- Change in nutritional status
- Change in use of medication
- Change in preload
- Conditions
- Sleep Problems, Haemodialysis
- Being tested
- Melatonin tablet 3 mg once daily, Placebo comparator
- Keywords
- sleep problems, quality of life, melatonin, sleep apnea, medication, preload, nutritional status, ProBNP
- Medical subject headings
- Parasomnias, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin tablet 3 mg once dailyDrug
Melatonin tablet 3 mg once daily
Placebo comparatorDrug
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| Melatonin | Active comparator | melatonin 3mg Receives: Drug: Melatonin tablet 3 mg once daily |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of vitality (dimension quality of life) by 15 points (RAND SF 36)
Measured: 6-12 months
Improvement general health by 15 points (dimension quality of life, RAND SF 36)
Measured: 6-12 months
Secondary outcomes (5)
Change in biochemical parameters
Measured: 3-6-9-12 months
Change in ProBNP
Measured: 12 months
Change in nutritional status
Measured: 12 months
Change in use of medication
Measured: 6-12 months
Change in preload
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2006 (estimated)
- Study startApr 2007
- Primary completionOct 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ProblemsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meander Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Kidney Foundation
- Investigators
- Pieter ter Wee, MD, PhD, Study chair, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00388661
- Sponsor's protocol ID
- R-06.31 M / Melody
- Other IDs
- R-06.31 M
- Status last verified
- Jul 2011
- First submitted
- 16 Oct 2006
- Last updated
- 20 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind Placebo-controlled Study on the Efficacy of Melatonin on Sleep, Resulting in an Improved Quality of Life in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT00388661
- Acronym / sponsor ID
- R-06.31 M / Melody
- Conditions
- Sleep Problems, Haemodialysis
- Keywords
- sleep problems, quality of life, melatonin, sleep apnea, medication, preload, nutritional status, ProBNP
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Meander Medical CenterUniversity, hospital or other
- Collaborators
- Dutch Kidney Foundation
- Study start
- Apr 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 17 Oct 2006 (estimated)
- 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.
Sleep problems can lead to a bad quality of life and a raise of morbidity, also in dialysis patients. Sleep problems can be caused by a disturbance of circadian rhythms in our body. For a good regulation of these circadian rhythms a uniform external synchronisation is necessary. This is the synchronisation of the biological clock of our body by light and other influences. In case of a disturbance of the external synchronisation, due to for example naps during the day or wake periods at night, internal rhythms can be unlinked. As a result a weakened melatonin rhythm and a problematic sleep-wake cycle can be observed. Most dialysis patients have sleep problems. Their sleep latency is prolonged. They often take a nap during the day and their sleep efficiency is poor. There has only been one study on the melatonin rhythm of dialysis patients. The conclusion of this study was that the melatonin rhythm of dialysis patients is weakened and disturbed, probably caused by renal insufficiency. In this study no link was made between melatonin rhythm and the nature and severity of possible sleep problems. In different studies with non-dialysis patients and a disturbed melatonin rhythm, exogenous melatonin at the right time leads to a recovery of the normal rhythm and the normal biological clock and a better quality of life.
The aim is to improve quality of life of hemodialysis patients with a placebo-controlled study with melatonin to investigate if exogenous melatonin can improve sleep problems and on the longer term improve quality of life (and secondary morbidity) of dialysis patients.
Detailed description
Objective of the study:
Does melatonin by improving sleep parameters improve quality of life of hemodialysis patients?
Study design:
Placebo-controlled, double-blind, randomized trial
Study population:
hemodialysis patients
Intervention:
melatonin 3 mg once daily (or placebo)
Primary study parameters/outcome of the study:
- improvement of vitality (dimension quality of life) by 15 points (RAND SF 36)
- improvement general health by 15 points (dimension quality of life, RAND SF 36)
Secondary study parameters/outcome of the study:
- Change in biochemical parameters
- Change in ProBNP
- Change in nutritional status
- Change in use of medication
- Change in preload
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melatonin | Active comparator | Drug: Melatonin tablet 3 mg once dailymelatonin 3mg |
| Placebo | Placebo comparator | Drug: Placebo comparator |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Informed Consent
- Man/Women between 18 and 85 years
- Understanding and knowledge of the dutch language
- End Stage Renal Disease, stable chronic hemodialysis > 3 months
- SpKt/V(total) > 1,2 pro dialysis
Key exclusion criteria (5 listed)
- Known major illness, which interferes with patient's participation in the study according to the investigator)or which results in a probable patient's survival of less than 1 year.
- Instable angina pectoris, heart failure NYHA class IV
- Pregnancy
- Current use of melatonin of known allergy of melatonin
- Participation in other medication/drug research within a month before inclusion
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 tablet 3 mg once dailyMelatonin tablet 3 mg once daily | Drug | Melatonin |
| Placebo comparatorPlacebo comparator | Drug | Placebo |
Primary outcome
Improvement of vitality (dimension quality of life) by 15 points (RAND SF 36)
Time frame: 6-12 months
Improvement general health by 15 points (dimension quality of life, RAND SF 36)
Time frame: 6-12 months
5 secondary outcomes
Change in biochemical parameters
Time frame: 3-6-9-12 months
Change in ProBNP
Time frame: 12 months
Change in nutritional status
Time frame: 12 months
Change in use of medication
Time frame: 6-12 months
Change in preload
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2011.
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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.
Pieter ter Wee, MD, PhD study chair
Amsterdam UMC, location VUmc
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Melatonin tablet 3 mg once daily in people with Sleep Problems and Haemodialysis, run by Meander Medical Center at 2 sites in Netherlands.
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 6 inclusion and 5 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: finished, as of the sponsor's last update on 20 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Improvement of vitality (dimension quality of life) by 15 points (RAND SF 36) (time frame: 6-12 months). The study lists 2 primary outcomes in all. 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 20 Jul 2011.