Sleep Wake Transition DisordersCNMINCT02548507
Nocturnal Leg Cramps in Geneva : an Observational Study
An observational study of Sleep Wake Transition Disorders and Nocturnal Leg Cramps, run by University of Geneva, Switzerland at 1 site in Switzerland.
Trial summary
Background : Nocturnal leg cramps (NLC) are defined as painful involuntary contractions of the lower limbs occurring during prolonged periods of rest, typically during the night. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Sleep Wake Transition Disorders, Nocturnal Leg Cramps
- How many people
- 129 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2015to Apr 2018
- How long will I take part?
- 3 Weeks
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of 50 years old or more, consulting primary care physicians in Geneva
Who may be able to join
- Patients of 50 years old or more,
- currently presenting NLC (The definition of NLC used for the purpose of the study is any cramp in the legs or feet, occurring during the sleep (eg long rest) period).
- coming to the practice for a planned consultation.
Who cannot join
- Patients suffering from a terminal illness
- from disorders affecting their ability to consent,
- not speaking French
- or not having a telephone.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence, Main Features and Treatment of Nocturnal Leg Cramps in Geneva: A Primary Care Prospective Observational Study
Background :
Nocturnal leg cramps (NLC) are defined as painful involuntary contractions of the lower limbs occurring during prolonged periods of rest, typically during the night. They may cause severe pain and sleep disturbance, and are particularly common among older adults, though they can occur in all decades of life. They are frequently unreported to physicians. To the investigators' knowledge, no epidemiological studies have been conducted in Switzerland, but in a general population survey carried out in the UK (n=233), the overall prevalence of NLC was 37% and the disorder was more prevalent in older subjects (>80 years old: 54%). Of those who experienced NLC, 40% had cramps three or more times per week and 6% nightly. Another study performed in older US veterans (n=515) showed that 56% suffered from NLC.
Read more
The precise cause of these cramps is unclear. Most NLC occurring in adults appear to be idiopathic, but potential contributing factors include low levels of certain minerals, extracellular fluid volume depletion and prolonged sitting or inappropriate leg position during sedentary activity.
Research question :
What are the prevalence and the main features of NLC in patients consulting primary care physicians (PCPs) in Geneva, and how do PCPs treat this affection?
Primary objective :
To compute the prevalence of NLC in patients consulting PCPs in Geneva, explore its main features (number, duration, severity and sleep disturbance) and assess how PCPs treat this affection.
Study design :
Prospective observational study using questionnaire and daily log completed by patients.
- Being tested
- observational study, no intervention
- Medical subject headings
- Sleep-Wake Transition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational study, no interventionOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of NLC
In order to compute the prevalence of NLC, the PCPs will be asked to specify for each patient coming for a planned consultation whether he/she has NLC, meets the inclusion criteria and accept to participate (group 1), has NLC, meets the inclusion criteria but refuses to participate (group 2) or has NLC but does not meet the inclusion criteria (group 3). For patients in the group 1 doctors will record the current date, the name and the first name, the gender, the date of birth and the phone number; for patients in the group 2 they will record the current date, the gender and the date of birth; and finally for patients in the group 3 they will record the current date, the gender, the date of birth and the exclusion criterion.
Measured: Presence or absence of NLC will be checked during the time of recruitment for each participant PCP, with expected average of 1 to 6 months.
Secondary outcomes (7)
Frequency of NLC
Voluntaries will record during two weeks the number of cramps in a daily log.
Measured: During two weeks after recruitment
Duration of nocturnal leg cramps
Voluntaries will record during two weeks the duration of cramps in a daily log.
Measured: During two weeks after recruitment
Severity of pain related with nocturnal leg cramps
Voluntaries will record the severity of cramps in a daily log, standardized on an analog numerical scale of 1 to 10 .
Measured: During two weeks after recruitment
Severity of sleep disturbance related with nocturnal leg cramps
Voluntaries will record the severity of sleep disturbance related with NLC, in a daily log, standardized on an analog numerical scale of 1 to 10.
Measured: During two weeks after recruitment
Patient expectancies for nocturnal leg cramps treatment
We will ask the voluntaries to specify the average pain and sleep disturbance related with NLC on analog numerical scale of 1 to 10. We'll then ask them what improvement they would expect from a treatment on the same analog numeric scale for pain and sleep disturbance.
Measured: Two weeks after recruitment
Patient quality of life
Voluntaries will fill a SF36 questionnaire
Measured: 1 year after initial recruitment
Patient quality of sleep
Voluntaries will fill a PSQI questionnaire
Measured: 1 year after initial recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2015 (estimated)
- Study startMar 2015
- Primary completionNov 2017
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Wake Transition DisordersStudies 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 129 participants (actual)
- Target duration
- 3 Weeks
Sponsor and investigators
- Lead sponsor
- University of Geneva, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maisonneuve Hubert, University of Geneva, Switzerland
- Investigators
- Hubert Maisonneuve, MD, Principal investigator, University of Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02548507
- Sponsor's protocol ID
- CNMI
- Acronym
- CNMI
- Status last verified
- May 2018
- First submitted
- 9 Sep 2015
- Last updated
- 22 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence, Main Features and Treatment of Nocturnal Leg Cramps in Geneva: A Primary Care Prospective Observational Study
- ClinicalTrials.gov ID
- NCT02548507
- Acronym / sponsor ID
- CNMI / CNMI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- University of Geneva, SwitzerlandUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 14 Sep 2015 (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.
Background :
Nocturnal leg cramps (NLC) are defined as painful involuntary contractions of the lower limbs occurring during prolonged periods of rest, typically during the night. They may cause severe pain and sleep disturbance, and are particularly common among older adults, though they can occur in all decades of life. They are frequently unreported to physicians. To the investigators' knowledge, no epidemiological studies have been conducted in Switzerland, but in a general population survey carried out in the UK (n=233), the overall prevalence of NLC was 37% and the disorder was more prevalent in older subjects (>80 years old: 54%). Of those who experienced NLC, 40% had cramps three or more times per week and 6% nightly. Another study performed in older US veterans (n=515) showed that 56% suffered from NLC.
The precise cause of these cramps is unclear. Most NLC occurring in adults appear to be idiopathic, but potential contributing factors include low levels of certain minerals, extracellular fluid volume depletion and prolonged sitting or inappropriate leg position during sedentary activity.
Research question :
What are the prevalence and the main features of NLC in patients consulting primary care physicians (PCPs) in Geneva, and how do PCPs treat this affection?
Primary objective :
To compute the prevalence of NLC in patients consulting PCPs in Geneva, explore its main features (number, duration, severity and sleep disturbance) and assess how PCPs treat this affection.
Study design :
Prospective observational study using questionnaire and daily log completed by patients.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Weeks
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of 50 years old or more, consulting primary care physicians in Geneva
Key inclusion criteria (3 listed)
- Patients of 50 years old or more,
- currently presenting NLC (The definition of NLC used for the purpose of the study is any cramp in the legs or feet, occurring during the sleep (eg long rest) period).
- coming to the practice for a planned consultation.
Key exclusion criteria (4 listed)
- Patients suffering from a terminal illness
- from disorders affecting their ability to consent,
- not speaking French
- or not having a telephone.
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 |
|---|---|---|
| observational study, no intervention | Other | – |
Primary outcome
Prevalence of NLC
Time frame: Presence or absence of NLC will be checked during the time of recruitment for each participant PCP, with expected average of 1 to 6 months.
In order to compute the prevalence of NLC, the PCPs will be asked to specify for each patient coming for a planned consultation whether he/she has NLC, meets the inclusion criteria and accept to participate (group 1), has NLC, meets the inclusion criteria but refuses to participate (group 2) or has NLC but does not meet the inclusion criteria (group 3). For patients in the group 1 doctors will record the current date, the name and the first name, the gender, the date of birth and the phone number; for patients in the group 2 they will record the current date, the gender and the date of birth; and finally for patients in the group 3 they will record the current date, the gender, the date of birth and the exclusion criterion.
7 secondary outcomes
Frequency of NLC
Time frame: During two weeks after recruitment
Duration of nocturnal leg cramps
Time frame: During two weeks after recruitment
Severity of pain related with nocturnal leg cramps
Time frame: During two weeks after recruitment
Severity of sleep disturbance related with nocturnal leg cramps
Time frame: During two weeks after recruitment
Patient expectancies for nocturnal leg cramps treatment
Time frame: Two weeks after recruitment
Patient quality of life
Time frame: 1 year after initial recruitment
Patient quality of sleep
Time frame: 1 year after initial recruitment
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 22 May 2018.
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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.
Hubert Maisonneuve, MD principal investigator
University of Geneva, Switzerland
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 Sleep Wake Transition Disorders and Nocturnal Leg Cramps, run by University of Geneva, Switzerland at 1 site in Switzerland.
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 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: finished, as of the sponsor's last update on 22 May 2018. 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 Switzerland. 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?
Prevalence of NLC (time frame: Presence or absence of NLC will be checked during the time of recruitment for each participant PCP, with expected average of 1 to 6 months.). 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 22 May 2018.