NarcolepsyNCT02913651
Cardiovascular Variability and Heart Rate Arousal Response in Idiopathic Hypersomnia
An observational study of Narcolepsy and Cataplexy, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Autonomic nervous system dysfunction has been described in narcolepsy with cataplexy affecting the sympathetic function. In this study the investigators analyzed whether altered diurnal and nocturnal cardiovascular control is present in idiopathic hypersomnia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Narcolepsy, Cataplexy
- What is being tested?
- Polysomnography
- Type of treatment
- Medical device
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2016to Dec 2016
- 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: Idiopathic hypersomnia patients and no idiopathic hypersomnia patient
Who may be able to join
- Idiopathic hypersomnia patients
- idiopathic hypersomnia diagnosis
- complaints of excessive daytime sleepiness for >1 year
- a night-time length >10 h for 3 weeks before polysomnography as assessed by a sleep diary
- no idiopathic hypersomnia patients
- no sleep complaints and excessive daytime sleepiness (Epworth sleep questionnaire score <10
Who cannot join
- Narcolepsy-cataplexy
- sleep irregularities and sleep deprivation symptoms
- lack of neurological or psychiatric diseases
- upper airway resistance syndrome
- periodic limbs movements
- cerebral lesion
- medication or drinks affecting sleep and wake state
Trial locations and contacts
1 site in 1 country.
About this study
Autonomic nervous system dysfunction has been described in narcolepsy with cataplexy affecting the sympathetic function. In this study the investigators analyzed whether altered diurnal and nocturnal cardiovascular control is present in idiopathic hypersomnia. Drug-free patients diagnosed with idiopathic hypersomnia and age-matched controls were included. Clinical data, 24-h polysomnography, heart rate variability and the heart rate response to spontaneous arousal are analyzed.
- Conditions
- Narcolepsy, Cataplexy
- Being tested
- Polysomnography
- Keywords
- Idiopathic hypersomnia, heart rate variability, parasympathetic activity, autonomic arousal response
- Medical subject headings
- Narcolepsy, Cataplexy, Idiopathic Hypersomnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolysomnographyDevice
The polysomnography, for both groups, was performed accordance with standard practice
| Study group | Role | What they receive |
|---|---|---|
| Idiopathic hypersomnia | Drug-free patients diagnosed with idiopathic hypersomnia from 01/01/11 to 15/09/15 Receives: Device: Polysomnography | |
| Controls | Patients with no sleep complaints, having a 24-h ambulatory ad libitum polysomnography Receives: Device: Polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
High Frequencies (HF)
Nocturnal parasympathetic activity (HF parameter of heart rate variability analysis)
Measured: During the polysomnography (one night)
Secondary outcomes (3)
Heart rate variability (HRV)
HRV is measured by the polysomnography. It is a composite outcome : Standard Deviation of NN intervals (SDNN), the proportion of NN30 (and 50) divided by total number of NNs (pNN30, pNN50), Root Mean Square of Successive Differences (RMSSD), Standard Deviation type 1 and 2 (SD1, SD2), Low Frequencies (LF), Very Low Frequencies (VLF), LF/HF ratio and Ptot indexes
Measured: During the polysomnography (one night)
Apnea-Hypopnea Index (AIH)
Measured: During the polysomnography (one night)
Epworth Sleepiness Scale (ESS)
It examines eight different situations using a 4-grade scale ranging from 0 (no chances of napping) to 3 (high chances of napping). Subjects were defined as sleepy if they had an ESS>10
Measured: Before the polysomnography (one night)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NarcolepsyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilia SFORZA, MD, Study chair, CHU de SAINT-ETIENNE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02913651
- Sponsor's protocol ID
- 1600111
- Status last verified
- Sep 2016
- First submitted
- 22 Sep 2016
- Last updated
- 25 Jan 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 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Variability and Heart Rate Arousal Response in Idiopathic Hypersomnia
- ClinicalTrials.gov ID
- NCT02913651
- Acronym / sponsor ID
- 1600111
- Conditions
- Narcolepsy, Cataplexy
- Keywords
- Idiopathic hypersomnia, heart rate variability, parasympathetic activity, autonomic arousal response
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 26 Sep 2016 (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.
Autonomic nervous system dysfunction has been described in narcolepsy with cataplexy affecting the sympathetic function. In this study the investigators analyzed whether altered diurnal and nocturnal cardiovascular control is present in idiopathic hypersomnia. Drug-free patients diagnosed with idiopathic hypersomnia and age-matched controls were included. Clinical data, 24-h polysomnography, heart rate variability and the heart rate response to spontaneous arousal are analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Idiopathic hypersomnia | – | Device: PolysomnographyDrug-free patients diagnosed with idiopathic hypersomnia from 01/01/11 to 15/09/15 |
| Controls | – | Device: PolysomnographyPatients with no sleep complaints, having a 24-h ambulatory ad libitum polysomnography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Idiopathic hypersomnia patients and no idiopathic hypersomnia patient
Key inclusion criteria (6 listed)
- Idiopathic hypersomnia patients
- idiopathic hypersomnia diagnosis
- complaints of excessive daytime sleepiness for >1 year
- a night-time length >10 h for 3 weeks before polysomnography as assessed by a sleep diary
- no idiopathic hypersomnia patients
Key exclusion criteria (7 listed)
- Narcolepsy-cataplexy
- sleep irregularities and sleep deprivation symptoms
- lack of neurological or psychiatric diseases
- upper airway resistance syndrome
- periodic limbs movements
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 |
|---|---|---|
| PolysomnographyThe polysomnography, for both groups, was performed accordance with standard practice | Device | Controls, Idiopathic hypersomnia |
Primary outcome
High Frequencies (HF)
Time frame: During the polysomnography (one night)
Nocturnal parasympathetic activity (HF parameter of heart rate variability analysis)
3 secondary outcomes
Heart rate variability (HRV)
Time frame: During the polysomnography (one night)
Apnea-Hypopnea Index (AIH)
Time frame: During the polysomnography (one night)
Epworth Sleepiness Scale (ESS)
Time frame: Before the polysomnography (one night)
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 25 Jan 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.
Emilia SFORZA, MD study chair
CHU 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 Narcolepsy and Cataplexy, 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 6 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 25 Jan 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?
High Frequencies (HF) (time frame: During the polysomnography (one night)). 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 25 Jan 2017.