Restless Legs SyndromePLMSNCT03076541
Cardiovascular Variability, Heart Rate Response, and Electromyogram Power Associated With Periodic Leg Movements.
An observational study of Restless Legs Syndrome, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Periodic leg movements during sleep is associated with microarousals and a stimulation of the sympathetic nervous system. The knowledge of this autonomic activation may help understanding the increase of cardiac risk observed in elderly. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Restless Legs Syndrome
- What is being tested?
- standard 24-h ambulatory polysomnography
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2016to Mar 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with restless legs syndrome with a diagnosis from January 1rst 2012 to september 1rst 2016.
Who may be able to join
- Restless legs syndrome patients
- Hospital routine for periodic leg movements diagnosis
- PLMS index > 0
Who cannot join
- Narcolepsy-cataplexy
- Sleep irregularities and sleep deprivation symptoms
- Lack of neurological or psychiatric diseases
- Upper airway resistance syndrome
- Obstructive sleep apnea
- Treatment, cerebral lesion, medical illness
- Medication or drinks affecting sleep and wake state
Trial locations and contacts
1 site in 1 country.
About this study
Periodic leg movements during sleep is associated with microarousals and a stimulation of the sympathetic nervous system. The knowledge of this autonomic activation may help understanding the increase of cardiac risk observed in elderly. The aim of the study is to evaluate the relationship between periodic leg movements severity, age, gender, electromyographic power and heart rate response associated with periodic leg movements. Drug-free patients diagnosed with periodic leg movements were included. Clinical data and 24-h polysomnography recordings were analyzed.
- Conditions
- Restless Legs Syndrome
- Being tested
- standard 24-h ambulatory polysomnography
- Keywords
- Restless legs syndrome, Periodic leg movements, Heart rate, Heart rate variability, Microarousals, Autonomic nervous system activity
- Medical subject headings
- Restless Legs Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard 24-h ambulatory polysomnographyDevice
A standard 24-h ambulatory ad libitum polysomnography including EEG, electro-oculography (EOG), electromyography (EMG), EKG, was performed by a standard clinical.
| Study group | Role | What they receive |
|---|---|---|
| patients with restless legs syndrome | Not described Receives: Device: standard 24-h ambulatory polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amplitude of heart rate response associated with periodic leg movements.
standard 24-h ambulatory ad libitum polysomnography
Measured: At diagnosis
Secondary outcomes (2)
Other Heart rate variability indices: Ptot, very-low-frequency (VLF), low frequency (LF), low frequency normalized units (LFnu), high-frequency normalized units (HFnu), LF/HF.
standard 24-h ambulatory ad libitum polysomnography
Measured: At diagnosis
electromyography (EMG) power
standard 24-h ambulatory ad libitum polysomnography
Measured: At diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2017
- Study start1 Sep 2016
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Restless Legs SyndromeStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent PICHOT, PhD, Study chair, Centre Hospitalier Universitaire de Saint EtienneEmilia SFORZA, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03076541
- Sponsor's protocol ID
- 1700175
- Acronym
- PLMS
- Status last verified
- Jul 2017
- First submitted
- 6 Mar 2017
- Last updated
- 6 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Variability, Heart Rate Response, and Electromyogram Power Associated With Periodic Leg Movements.
- ClinicalTrials.gov ID
- NCT03076541
- Acronym / sponsor ID
- PLMS / 1700175
- Conditions
- Restless Legs Syndrome
- Keywords
- Restless legs syndrome, Periodic leg movements, Heart rate, Heart rate variability, Microarousals, Autonomic nervous system activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 10 Mar 2017 (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.
Periodic leg movements during sleep is associated with microarousals and a stimulation of the sympathetic nervous system. The knowledge of this autonomic activation may help understanding the increase of cardiac risk observed in elderly. The aim of the study is to evaluate the relationship between periodic leg movements severity, age, gender, electromyographic power and heart rate response associated with periodic leg movements. Drug-free patients diagnosed with periodic leg movements were included. Clinical data and 24-h polysomnography recordings were analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with restless legs syndrome | – | Device: standard 24-h ambulatory polysomnography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with restless legs syndrome with a diagnosis from January 1rst 2012 to september 1rst 2016.
Key inclusion criteria (3 listed)
- Restless legs syndrome patients
- Hospital routine for periodic leg movements diagnosis
- PLMS index > 0
Key exclusion criteria (7 listed)
- Narcolepsy-cataplexy
- Sleep irregularities and sleep deprivation symptoms
- Lack of neurological or psychiatric diseases
- Upper airway resistance syndrome
- Obstructive sleep apnea
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 |
|---|---|---|
| standard 24-h ambulatory polysomnographyA standard 24-h ambulatory ad libitum polysomnography including EEG, electro-oculography (EOG), electromyography (EMG), EKG, was performed by a standard clinical. | Device | patients with restless legs syndrome |
Primary outcome
Amplitude of heart rate response associated with periodic leg movements.
Time frame: At diagnosis
standard 24-h ambulatory ad libitum polysomnography
2 secondary outcomes
Other Heart rate variability indices: Ptot, very-low-frequency (VLF), low frequency (LF), low frequency normalized units (LFnu), high-frequency normalized units (HFnu), LF/HF.
Time frame: At diagnosis
electromyography (EMG) power
Time frame: At diagnosis
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 6 Jul 2017.
- Individual participant dataSharing planned: No
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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.
Vincent PICHOT, PhD study chair
Centre Hospitalier Universitaire de Saint Etienne
Emilia SFORZA, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
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 Restless Legs Syndrome, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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 3 inclusion and 7 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 6 Jul 2017. 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 France. 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 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?
Amplitude of heart rate response associated with periodic leg movements. (time frame: At diagnosis). 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 6 Jul 2017.