NarcolepsyNCT02077036
Narcolepsy - New Potential Treatment
A study testing Kinetic Oscillation Stimulation Device in people with Narcolepsy, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
The overall aim of the study is to investigate the effect of a new, non-pharmacological method that may alleviate the symptoms of narcolepsy and thereby lead to a reduction in the use of medications with potentially serious side effects in patients with this disease. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Narcolepsy
- What is being tested?
- Kinetic Oscillation Stimulation Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- Start not givento Dec 2014
- Phase
- Interventional
- 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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Signed informed consent
- Diagnosed with narcolepsy (diagnose code G47.4)
- 16 - 60 years of age
- MSLT has shown hypersomnia (sleeping latency < 8 min) \& 1 episode REM
- HLA-type associated with increased occurrence of narcolepsy
Who cannot join
- Reduced cognitive function
- Other relevant organ disease (that could affect the study results or put the patient at risk)
- Ongoing bacterial infection in the nose
- Comorbidity that can increase the risk of bleeding
- Has received treatment with an implantable stimulator or other implantable product in the head and / or in the neck
- Known pronounced septal deviation
Show all 9Show fewer
- Known allergy to polyvinylchloride or medicinal liquid paraffin
- Women not using adequate contraceptives
- Participated in a clinical investigational drug trial within the previous 30 days
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm
Lars Hyllienmark, MD, PhD
About this study
The overall aim of the study is to investigate the effect of a new, non-pharmacological method that may alleviate the symptoms of narcolepsy and thereby lead to a reduction in the use of medications with potentially serious side effects in patients with this disease.
- Conditions
- Narcolepsy
- Being tested
- Kinetic Oscillation Stimulation Device, Kinetic Oscillation Stimulation Device in placebo mode
- Medical subject headings
- Narcolepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinetic Oscillation Stimulation DeviceDevice
Kinetic Oscillation Stimulation Device in placebo modeDevice
| Study group | Role | What they receive |
|---|---|---|
| Active medical device | Experimental | Not described Receives: Device: Kinetic Oscillation Stimulation Device |
| Inactive medical device | Placebo comparator | Not described Receives: Device: Kinetic Oscillation Stimulation Device in placebo mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in scale Epworth Sleep Scale (ESS)
Change in ESS scale between baseline before treatment and at 15-21 days after treatment.
Measured: 15-21 days
Secondary outcomes (1)
Change in multiple sleep latency test (MSLT)
Change in MSLT (mean sleep latency, number of sleep onset rapid eye movement (SOREM), and mean SOREM latency) between registration at baseline and 14 days after treatment.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2014 (estimated)
- Primary completionDec 2014 (estimated)
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.
- 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lars Hyllienmark, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02077036
- Sponsor's protocol ID
- nervus11
- Status last verified
- Feb 2014
- First submitted
- 11 Feb 2014
- Last updated
- 4 Mar 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Narcolepsy - New Potential Treatment
- ClinicalTrials.gov ID
- NCT02077036
- Acronym / sponsor ID
- nervus11
- Conditions
- Narcolepsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Primary completion
- Dec 2014 (estimated)
- First posted
- 4 Mar 2014 (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.
The overall aim of the study is to investigate the effect of a new, non-pharmacological method that may alleviate the symptoms of narcolepsy and thereby lead to a reduction in the use of medications with potentially serious side effects in patients with this disease.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active medical device | Experimental | Device: Kinetic Oscillation Stimulation Device |
| Inactive medical device | Placebo comparator | Device: Kinetic Oscillation Stimulation Device in placebo mode |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Signed informed consent
- Diagnosed with narcolepsy (diagnose code G47.4)
- 16 - 60 years of age
- MSLT has shown hypersomnia (sleeping latency < 8 min) \& 1 episode REM
- HLA-type associated with increased occurrence of narcolepsy
Key exclusion criteria (9 listed)
- Reduced cognitive function
- Other relevant organ disease (that could affect the study results or put the patient at risk)
- Ongoing bacterial infection in the nose
- Comorbidity that can increase the risk of bleeding
- Has received treatment with an implantable stimulator or other implantable product in the head and / or in the neck
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 |
|---|---|---|
| Kinetic Oscillation Stimulation Device | Device | Active medical device |
| Kinetic Oscillation Stimulation Device in placebo mode | Device | Inactive medical device |
Primary outcome
Change in scale Epworth Sleep Scale (ESS)
Time frame: 15-21 days
Change in ESS scale between baseline before treatment and at 15-21 days after treatment.
1 secondary outcome
Change in multiple sleep latency test (MSLT)
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinetic Oscillation Stimulation Device in people with Narcolepsy, run by Karolinska University Hospital at 1 site in Sweden.
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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 4 Mar 2014. 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 Sweden. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lars Hyllienmark, MD, PhD (+46-8-517 729 79, lars.hyllienmark@karolinska.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in scale Epworth Sleep Scale (ESS) (time frame: 15-21 days). 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 4 Mar 2014.