Nocturnal HypokinesiaNCT01554306
Measuring the Effects of Continuous Dopaminergic Stimulation on Nocturnal Movements in Parkinson's Disease
An observational study of Nocturnal Hypokinesia and Parkinsons's Disease, run by Sleep Medicine Centre Kempenhaeghe at 1 site in Netherlands.
Trial summary
Parkinson's disease (PD) is a neurodegenerative disorder that is characterized with motor symptoms such as hypokinesia, rigidity, tremor and postural instability. These symptoms can also be present during the night. Half of the patients with PD have difficulty turning around in bed. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Nocturnal Hypokinesia, Parkinsons's Disease, Rotigotine
- How many people
- 2 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2012to Sep 2014
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with Parkinson's disease with nocturnal hypokinesia based on the clinical interview who are going to start with rotigotine
Who may be able to join
- Patients with idiopathic PD (defined by UK Brain Bank criteria)
- Patients who will start treatment with rotigotine
- Hoehn \& Yahr stage II - IV
- Subjective sleep problems most likely caused by nocturnal hypokinesia, based on clinical interview
Who cannot join
- Other significant causes for nocturnal motor symptoms which are not dopamine-responsive
- Previous surgery for PD
- Mini- mental state examination score < 25
- Concurrent hallucination or psychosis
- History of skin hypersensitivity to adhesives or other transdermals
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study on the Effecst of Continuous Dopaminergic Stimulation on Nocturnal Hypokinesia in Parkinson's Disease
Parkinson's disease (PD) is a neurodegenerative disorder that is characterized with motor symptoms such as hypokinesia, rigidity, tremor and postural instability. These symptoms can also be present during the night. Half of the patients with PD have difficulty turning around in bed. This nocturnal hypokinesia is considered as a possible cause of sleep problems in this population. The diagnosis nocturnal hypokinesia is based on the clinical interview. There is a need for a diagnostic devices that measures nocturnal movements, preferably in the home setting. This device can be used in the diagnostic trajectory as well in the evaluation of treatment. Recently the Dynaport Minimod (McRoberts, The Hague) has been developed to register nocturnal movements. The tri-axial accelerometer has been developed to measure position changes in the night. A validation study with actigraphy and polysomnography concluded that the Dynaport MiniMod is a valid an feasible device for assessing intensity and physical activity and changes of body position during sleep.
Nocturnal hypokinesia is treated with nocturnal dopamine. Sometimes a night-time dose of dopaminergics is adequate, but most of the time slow release dopaminergics are needed. However response fluctuations can negatively influence the treatment. In these cases continuous dopaminergic stimulation is needed, such as rotigotine. Rotigotine treats response fluctuations during the day and studies show that sleep quality measured with questionnaires improves. If the improvement of sleep quality is caused by improved bed mobility has not been studied yet. The study hypothesis is that rotigotine does not influence nocturnal hypokinesia in PD.
Read more
Objective of the study:
Primary:
- To study the effect of rotigotine on nocturnal hypokinesia
Secondary:
- To study the possibility of measuring nocturnal hypokinesia and its severity in a home setting
- To correlate improvements in sleep quality by rotigotine with changes in nocturnal hypokinesia
Study design:
We will study patients who will recieve rotigotine as a part of their usual care. During three nights, nocturnal movements are being registered with movement sensors, before treatment has started as well as after a stable medication dose of one month. We will also assess sleep quality with questionnaires.
Study population:
The study population are patients with Parkinson's disease with sleep problems caused by nocturnal hypokinesia, who will start treatment with rotigotine. Patients will be recruited in the neurology patient outdoor clinic of the Radboud University Medical Centre Nijmegen. We will ask the treating neurologist to inform us when a patient will start treatment with rotigotine. One of the researchers will contact the patient to give further information about the study. The study is a first hypothesis generating study and we will start with the inclusion of 10 patients.
Intervention (if applicable):
Primary study parameters/outcome of the study:
Position changes over the night.
Secundary study parameters/outcome of the study (if applicable):
Objective
- Degree of mobility, measured as the speed of the movements
- Total amount of movements
- Score on the motor symptom scale according to the MDS-UPDRS part III
Subjective
- Nocturnal sleep quality Excessive daytime sleepiness
- Presence of nocturnal akinesia
- Conditions
- Nocturnal Hypokinesia, Parkinsons's Disease, Rotigotine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| parkinson's disease, nocturnal hypokinesia, rotigotine | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Position changes over the night.
Measured: max 1 year
Secondary outcomes (3)
• Degree of mobility, measured as the speed of the movements
Measured: Max 1 year
• Total amount of movements
Measured: Max 1 year
• Score on the motor symptom scale according to the MDS-UPDRS part III
Measured: Max 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionSep 2014
- Study completionSep 2014
Why it stopped: difficulty to include enough subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nocturnal HypokinesiaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sleep Medicine Centre Kempenhaeghe
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, D.A.A. Pevernagie, MD PhD, Sleep Medicine Centre Kempenhaeghe
- Investigators
- Dirk AA Pevernagie, MD PhD, Study director, Sleep Medicine Centre Kempenhaeghe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01554306
- Sponsor's protocol ID
- 38851.091.11
- Status last verified
- Oct 2016
- First submitted
- 5 Mar 2012
- Last updated
- 31 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on the Effecst of Continuous Dopaminergic Stimulation on Nocturnal Hypokinesia in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01554306
- Acronym / sponsor ID
- 38851.091.11
- Conditions
- Nocturnal Hypokinesia, Parkinsons's Disease, Rotigotine
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: difficulty to include enough subjects
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Sleep Medicine Centre KempenhaegheUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 14 Mar 2012 (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.
Parkinson's disease (PD) is a neurodegenerative disorder that is characterized with motor symptoms such as hypokinesia, rigidity, tremor and postural instability. These symptoms can also be present during the night. Half of the patients with PD have difficulty turning around in bed. This nocturnal hypokinesia is considered as a possible cause of sleep problems in this population. The diagnosis nocturnal hypokinesia is based on the clinical interview. There is a need for a diagnostic devices that measures nocturnal movements, preferably in the home setting. This device can be used in the diagnostic trajectory as well in the evaluation of treatment. Recently the Dynaport Minimod (McRoberts, The Hague) has been developed to register nocturnal movements. The tri-axial accelerometer has been developed to measure position changes in the night. A validation study with actigraphy and polysomnography concluded that the Dynaport MiniMod is a valid an feasible device for assessing intensity and physical activity and changes of body position during sleep.
Nocturnal hypokinesia is treated with nocturnal dopamine. Sometimes a night-time dose of dopaminergics is adequate, but most of the time slow release dopaminergics are needed. However response fluctuations can negatively influence the treatment. In these cases continuous dopaminergic stimulation is needed, such as rotigotine. Rotigotine treats response fluctuations during the day and studies show that sleep quality measured with questionnaires improves. If the improvement of sleep quality is caused by improved bed mobility has not been studied yet. The study hypothesis is that rotigotine does not influence nocturnal hypokinesia in PD.
Objective of the study:
Primary:
- To study the effect of rotigotine on nocturnal hypokinesia
Secondary:
- To study the possibility of measuring nocturnal hypokinesia and its severity in a home setting
- To correlate improvements in sleep quality by rotigotine with changes in nocturnal hypokinesia
Study design:
We will study patients who will recieve rotigotine as a part of their usual care. During three nights, nocturnal movements are being registered with movement sensors, before treatment has started as well as after a stable medication dose of one month. We will also assess sleep quality with questionnaires.
Study population:
The study population are patients with Parkinson's disease with sleep problems caused by nocturnal hypokinesia, who will start treatment with rotigotine. Patients will be recruited in the neurology patient outdoor clinic of the Radboud University Medical Centre Nijmegen. We will ask the treating neurologist to inform us when a patient will start treatment with rotigotine. One of the researchers will contact the patient to give further information about the study. The study is a first hypothesis generating study and we will start with the inclusion of 10 patients.
Intervention (if applicable):
Primary study parameters/outcome of the study:
Position changes over the night.
Secundary study parameters/outcome of the study (if applicable):
Objective
- Degree of mobility, measured as the speed of the movements
- Total amount of movements
- Score on the motor symptom scale according to the MDS-UPDRS part III
Subjective
- Nocturnal sleep quality Excessive daytime sleepiness
- Presence of nocturnal akinesia
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| parkinson's disease, nocturnal hypokinesia, rotigotine | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Parkinson's disease with nocturnal hypokinesia based on the clinical interview who are going to start with rotigotine
Key inclusion criteria (4 listed)
- Patients with idiopathic PD (defined by UK Brain Bank criteria)
- Patients who will start treatment with rotigotine
- Hoehn \& Yahr stage II - IV
- Subjective sleep problems most likely caused by nocturnal hypokinesia, based on clinical interview
Key exclusion criteria (5 listed)
- Other significant causes for nocturnal motor symptoms which are not dopamine-responsive
- Previous surgery for PD
- Mini- mental state examination score < 25
- Concurrent hallucination or psychosis
- History of skin hypersensitivity to adhesives or other transdermals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Position changes over the night.
Time frame: max 1 year
3 secondary outcomes
• Degree of mobility, measured as the speed of the movements
Time frame: Max 1 year
• Total amount of movements
Time frame: Max 1 year
• Score on the motor symptom scale according to the MDS-UPDRS part III
Time frame: Max 1 year
Results and safety
The study was stopped early (reason given: difficulty to include enough subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2016.
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.
Dirk AA Pevernagie, MD PhD study director
Sleep Medicine Centre Kempenhaeghe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nocturnal Hypokinesia and Parkinsons's Disease, run by Sleep Medicine Centre Kempenhaeghe at 1 site 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 4 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: stopped early, as of the sponsor's last update on 31 Oct 2016. 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 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. 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?
The study was stopped early (reason given: difficulty to include enough subjects). 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?
Position changes over the night. (time frame: max 1 year). 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 31 Oct 2016.