Disorders of Excessive SomnolenceNCT02884505
Improving the Assessment of Hypersomnolence
An observational study of Disorders of Excessive Somnolence, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The overall purpose of this study is to employ a pragmatic, multidimensional assessment of hypersomnolence that "piggybacks" on routine clinical care in patients with suspected disorders of central nervous system (CNS) hypersomnia, to determine whether these additional objective and subjective assessments are useful… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Disorders of Excessive Somnolence
- What is being tested?
- Pupillometry, Psychomotor Vigilance Task and Auditory Evoked Potential
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2017to 30 Jun 2019
- 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred for polysomnography and multiple sleep latency test at the University of Wisconsin-Madison
Who may be able to join
- Age 18-89
- Referred for polysomnography/multiple sleep latency test at Wisconsin Sleep, the sleep medicine clinic and laboratory of the University of Wisconsin-Madison
Who cannot join
- unstable medical condition that, in the opinion of the investigators, would make it unsafe for the subject to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin-Madison, Department of Psychiatry
Madison, Wisconsin, 53719
About this study
The overall purpose of this study is to employ a pragmatic, multidimensional assessment of hypersomnolence that "piggybacks" on routine clinical care in patients with suspected disorders of central nervous system (CNS) hypersomnia, to determine whether these additional objective and subjective assessments are useful in the diagnosis and management of these patients.
- Conditions
- Disorders of Excessive Somnolence
- Being tested
- Pupillometry, Psychomotor Vigilance Task, Auditory Evoked Potential, Hypersomnia Severity Index
- Medical subject headings
- Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PupillometryDevice
Measures pupillary dynamics in darkness and light conditions
Psychomotor Vigilance TaskBehavioural
Response time task measuring neurobehavioral alertness
Auditory Evoked PotentialOther
Measure of electroencephalographic response to standardized auditory tones
Hypersomnia Severity IndexBehavioural
Self-report measure of hypersomnolence
| Study group | Role | What they receive |
|---|---|---|
| Patients with Hypersomnolence | Patients referred for polysomnography and multiple sleep latency test Receives: Device: Pupillometry; Behavioral: Psychomotor Vigilance Task; Other: Auditory Evoked Potential; Behavioral: Hypersomnia Severity Index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients Categorized with Hypersomnolence
Multiple measurements will be aggregated to arrive at the primary outcome of proportion of patients categorized as having hypersomnolence using either standard assessments or standard assessments plus additional novel hypersomnolence measures of pupillometry, psychomotor vigilance task, and auditory evoked potentials. Proportion of patients with hypersomnolence using standard measures will be calculated as number of patients with mean sleep latency (MSL) on multiple sleep latency test (MSLT) <8 minutes divided by total number of patients. Proportion of patients categorized as having hypersomnolence with additional novel hypersomnolence measures will be calculated as the number of patients with MSL<8 minutes, and/or pupillary unrest index (PUI) >8.9 on pupillometry, and/or PVT lapses >3, and/or P300 delay/sleep negativity during auditory evoked potentials divided by total number of patients.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study start25 Aug 2017
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorders of Excessive SomnolenceStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David T Plante, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02884505
- Sponsor's protocol ID
- 2015-1462
- Status last verified
- Aug 2019
- First submitted
- 16 Aug 2016
- Last updated
- 22 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Assessment of Hypersomnolence
- ClinicalTrials.gov ID
- NCT02884505
- Acronym / sponsor ID
- 2015-1462
- Conditions
- Disorders of Excessive Somnolence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 25 Aug 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 31 Aug 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.
The overall purpose of this study is to employ a pragmatic, multidimensional assessment of hypersomnolence that "piggybacks" on routine clinical care in patients with suspected disorders of central nervous system (CNS) hypersomnia, to determine whether these additional objective and subjective assessments are useful in the diagnosis and management of these patients.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Hypersomnolence | – | Device: Pupillometry, Behavioral: Psychomotor Vigilance Task, Other: Auditory Evoked Potential, Behavioral: Hypersomnia Severity IndexPatients referred for polysomnography and multiple sleep latency test |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred for polysomnography and multiple sleep latency test at the University of Wisconsin-Madison
Key inclusion criteria (2 listed)
- Age 18-89
- Referred for polysomnography/multiple sleep latency test at Wisconsin Sleep, the sleep medicine clinic and laboratory of the University of Wisconsin-Madison
Key exclusion criteria (1 listed)
- unstable medical condition that, in the opinion of the investigators, would make it unsafe for the subject to participate
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 |
|---|---|---|
| PupillometryMeasures pupillary dynamics in darkness and light conditions | Device | Patients with Hypersomnolence |
| Psychomotor Vigilance TaskResponse time task measuring neurobehavioral alertness | Behavioural | Patients with Hypersomnolence |
| Auditory Evoked PotentialMeasure of electroencephalographic response to standardized auditory tones | Other | Patients with Hypersomnolence |
| Hypersomnia Severity IndexSelf-report measure of hypersomnolence | Behavioural | Patients with Hypersomnolence |
Primary outcome
Proportion of Patients Categorized with Hypersomnolence
Time frame: 2 Years
Multiple measurements will be aggregated to arrive at the primary outcome of proportion of patients categorized as having hypersomnolence using either standard assessments or standard assessments plus additional novel hypersomnolence measures of pupillometry, psychomotor vigilance task, and auditory evoked potentials. Proportion of patients with hypersomnolence using standard measures will be calculated as number of patients with mean sleep latency (MSL) on multiple sleep latency test (MSLT) <8 minutes divided by total number of patients. Proportion of patients categorized as having hypersomnolence with additional novel hypersomnolence measures will be calculated as the number of patients with MSL<8 minutes, and/or pupillary unrest index (PUI) >8.9 on pupillometry, and/or PVT lapses >3, and/or P300 delay/sleep negativity during auditory evoked potentials divided by total number of patients.
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 Aug 2019.
- 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.
David T Plante, MD principal investigator
University of Wisconsin, Madison
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 Disorders of Excessive Somnolence, run by University of Wisconsin, Madison at 1 site in United States.
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 2 inclusion and 1 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 Aug 2019. 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 United States. 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?
Proportion of Patients Categorized with Hypersomnolence (time frame: 2 Years). 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 Aug 2019.