NarcolepsyNCT05371483
Cardiovascular and Cognitive Implications of Central Disorders of Hypersomnolence and Their Treatments
An observational study of Narcolepsy and Idiopathic Hypersomnia, run by Mayo Clinic at 1 site in United States.
Trial summary
This is an observational study evaluating patients diagnosed with narcolepsy or idiopathic hypersomnia that have been prescribed a new/different hypersomnia treatment. The study is being done to better understand how hypersomnia treatment(s) impact blood pressure and cognitive function. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Narcolepsy, Idiopathic Hypersomnia
- What is being tested?
- 24-hour Ambulatory Blood Pressure Monitoring and Oculo-Cognitive Addition Test (OCAT)
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2022to Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with narcolepsy or idiopathic hypersomnia that have been prescribed but not yet started a new/different hypersomnia medication.
Who may be able to join
- Diagnosed with narcolepsy or idiopathic hypersomnia according to International Classification of Sleep Disorders, third edition
- Age 18 - 75 years
- BMI between 18 and 40 kg/m2
- Prescribed a medication of interest (e.g., sodium oxybate, low sodium oxybate, pitolisant, modafinil/armodafinil, solriamfetol, traditional stimulant(s)) by a clinical sleep specialist as part of routine medical care.
- Subject must be willing to postpone starting medication until after completion of baseline assessment(s).
- If subject has been taking a prescribed hypersomnia medication(s) at a stable dose for at least 3 months and has been prescribed a new medication, then subject may complete baseline assessment(s) while taking initial hypersomnia medication(s) before starting new medication.
Who cannot join
- Any change to medication(s) within the last 45 days
- History of chronic alcohol or drug abuse within the prior 12 months
- Heart failure, history of severe hypertension, or other cardiovascular disease compromising the patient's wellbeing or ability to participate in this study
- Use of any sleep apnea treatment (e.g., Positive Airway Pressure (PAP) therapy, oral appliance therapy, etc.) within 45 days of baseline assessment visit
- Participation in another study of an investigational drug within the 28 days prior to screening visit or currently
- Pregnancy and/or breast-feeding
- Subjects who, in the opinion of the Investigator, may not be suitable for the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This is an observational study evaluating patients diagnosed with narcolepsy or idiopathic hypersomnia that have been prescribed a new/different hypersomnia treatment. The study is being done to better understand how hypersomnia treatment(s) impact blood pressure and cognitive function.
Read the detailed description
This is an observational study evaluating how hypersomnia medications influence blood pressure and cognitive function in patients diagnosed with narcolepsy or idiopathic hypersomnia. Blood pressure will be assessed using 24-hour ambulatory blood pressure monitoring equipment. Cognitive function will be evaluated using the Oculo-Cognitive Addition Test (OCAT). Both tests will performed at baseline (e.g., before starting a new hypersomnia medication) and after taking a stable dose of the new hypersomnia medication for at least three months. All medications will be prescribed by a clinical sleep specialist as part of routine medical care and covered by subject's health insurance plan (i.e., no medications are dispensed/titrated/paid for by the study investigators/trial).
The 24-hour ambulatory blood pressure test will be setup in person by staff. During the blood pressure test, the study participant will also complete a sleep diary and wear an actigraphy watch to track activity and sleep-wake cycle. The 24-hour ambulatory blood pressure test will be programmed to inflate a blood pressure cuff placed around the arm every 15 - 30 minutes.
The OCAT test, which takes approximately 15-20 minutes to complete, will be completed in person as well.
Each study participant may complete one or both tests. Each study participant may complete more than two assessments (e.g., patient that has been prescribed a second hypersomnia medication). If a patient presents already taking a medication of interest at baseline for at least the last 3 months then the participant may undergo baseline assessment(s) while taking respective medication(s).
- Conditions
- Narcolepsy, Idiopathic Hypersomnia
- Being tested
- 24-hour Ambulatory Blood Pressure Monitoring, Oculo-Cognitive Addition Test (OCAT)
- Keywords
- Central Disorders of Hypersomnolence, Blood pressure, Cognitive function, narcolepsy, idiopathic hypersomnia
- Medical subject headings
- Narcolepsy, Idiopathic Hypersomnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24-hour Ambulatory Blood Pressure MonitoringDiagnostic test
Also called Actigraphy, Sleep diary
Arm blood pressure cuff that will automatically inflate every 15-30 minutes to check blood pressure while awake and asleep over 24 hours. Patient will also complete a sleep diary and wear an actigraphy watch during this test.
Oculo-Cognitive Addition Test (OCAT)Diagnostic test
Tracks users' eye movements as they complete a simple mental addition test.
| Study group | Role | What they receive |
|---|---|---|
| Narcolepsy Type 1 | Study participant will complete test(s) before and after taking a stable dose of a new/different hypersomnia medication. All hypersomnia medications will be prescribed and titrated by a clinical sleep specialist outside of this protocol. Receives: Diagnostic Test: 24-hour Ambulatory Blood Pressure Monitoring; Diagnostic Test: Oculo-Cognitive Addition Test (OCAT) | |
| Narcolepsy Type 2 | Study participant will complete test(s) before and after taking a stable dose of a new/different hypersomnia medication. All hypersomnia medications will be prescribed and titrated by a clinical sleep specialist outside of this protocol. Receives: Diagnostic Test: 24-hour Ambulatory Blood Pressure Monitoring; Diagnostic Test: Oculo-Cognitive Addition Test (OCAT) | |
| Idiopathic Hypersomnia | Study participant will complete test(s) before and after taking a stable dose of a new/different hypersomnia medication. All hypersomnia medications will be prescribed and titrated by a clinical sleep specialist outside of this protocol. Receives: Diagnostic Test: 24-hour Ambulatory Blood Pressure Monitoring; Diagnostic Test: Oculo-Cognitive Addition Test (OCAT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean 24-hour ambulatory blood pressure
Change in 24-hour ambulatory blood pressure from baseline (pre-treatment) to after taking a stable dose of medication for at least 3 months
Measured: Baseline, at least 3 months
Secondary outcomes (3)
Change in Oculo-Cognitive Addition Test (OCAT) completion time
Change in OCAT completion time from baseline (pre-treatment) to after taking a stable dose of medication for at least 3 months (post-treatment)
Measured: Baseline, at least 3 months
Change in mean daytime and nighttime 24-hour ambulatory blood pressure
Change in mean daytime and nighttime 24-hour ambulatory blood pressure from baseline (pre-treatment) to after taking a stable dose of medication for at least 3 months (post-treatment)
Measured: Baseline, at least 3 months
Change in 24-hour ambulatory blood pressure diurnal pattern (dipper versus non-dipper)
Change in 24-hour ambulatory blood pressure diurnal pattern (dipper versus non-dipper) from baseline (pre-treatment) to after taking a stable dose of medication for at least 3 months (post-treatment)
Measured: Baseline, at least 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start18 May 2022
- Primary completionMay 2028 (estimated)
- Study completionJul 2028 (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.
- More trials run by Mayo ClinicThe 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chad M. Ruoff, Mayo Clinic
- Investigators
- Chad Ruoff, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05371483
- Sponsor's protocol ID
- 21-013321
- Status last verified
- Jun 2026
- First submitted
- 9 May 2022
- Last updated
- 9 Jun 2026
- 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 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular and Cognitive Implications of Central Disorders of Hypersomnolence and Their Treatments
- ClinicalTrials.gov ID
- NCT05371483
- Acronym / sponsor ID
- 21-013321
- Conditions
- Narcolepsy, Idiopathic Hypersomnia
- Keywords
- Central Disorders of Hypersomnolence, Blood pressure, Cognitive function, narcolepsy, idiopathic hypersomnia
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 18 May 2022 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 12 May 2022 (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.
This is an observational study evaluating patients diagnosed with narcolepsy or idiopathic hypersomnia that have been prescribed a new/different hypersomnia treatment. The study is being done to better understand how hypersomnia treatment(s) impact blood pressure and cognitive function.
Detailed description
This is an observational study evaluating how hypersomnia medications influence blood pressure and cognitive function in patients diagnosed with narcolepsy or idiopathic hypersomnia. Blood pressure will be assessed using 24-hour ambulatory blood pressure monitoring equipment. Cognitive function will be evaluated using the Oculo-Cognitive Addition Test (OCAT). Both tests will performed at baseline (e.g., before starting a new hypersomnia medication) and after taking a stable dose of the new hypersomnia medication for at least three months. All medications will be prescribed by a clinical sleep specialist as part of routine medical care and covered by subject's health insurance plan (i.e., no medications are dispensed/titrated/paid for by the study investigators/trial).
The 24-hour ambulatory blood pressure test will be setup in person by staff. During the blood pressure test, the study participant will also complete a sleep diary and wear an actigraphy watch to track activity and sleep-wake cycle. The 24-hour ambulatory blood pressure test will be programmed to inflate a blood pressure cuff placed around the arm every 15 - 30 minutes.
The OCAT test, which takes approximately 15-20 minutes to complete, will be completed in person as well.
Each study participant may complete one or both tests. Each study participant may complete more than two assessments (e.g., patient that has been prescribed a second hypersomnia medication). If a patient presents already taking a medication of interest at baseline for at least the last 3 months then the participant may undergo baseline assessment(s) while taking respective medication(s).
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Narcolepsy Type 1 | – | Diagnostic Test: 24-hour Ambulatory Blood Pressure Monitoring, Diagnostic Test: Oculo-Cognitive Addition Test (OCAT)Study participant will complete test(s) before and after taking a stable dose of a new/different hypersomnia medication. All hypersomnia medications will be prescribed and titrated by a clinical sleep specialist outside of this protocol. |
| Narcolepsy Type 2 | – | Diagnostic Test: 24-hour Ambulatory Blood Pressure Monitoring, Diagnostic Test: Oculo-Cognitive Addition Test (OCAT)Study participant will complete test(s) before and after taking a stable dose of a new/different hypersomnia medication. All hypersomnia medications will be prescribed and titrated by a clinical sleep specialist outside of this protocol. |
| Idiopathic Hypersomnia | – | Diagnostic Test: 24-hour Ambulatory Blood Pressure Monitoring, Diagnostic Test: Oculo-Cognitive Addition Test (OCAT)Study participant will complete test(s) before and after taking a stable dose of a new/different hypersomnia medication. All hypersomnia medications will be prescribed and titrated by a clinical sleep specialist outside of this protocol. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with narcolepsy or idiopathic hypersomnia that have been prescribed but not yet started a new/different hypersomnia medication.
Key inclusion criteria (6 listed)
- Diagnosed with narcolepsy or idiopathic hypersomnia according to International Classification of Sleep Disorders, third edition
- Age 18 - 75 years
- BMI between 18 and 40 kg/m2
- Prescribed a medication of interest (e.g., sodium oxybate, low sodium oxybate, pitolisant, modafinil/armodafinil, solriamfetol, traditional stimulant(s)) by a clinical sleep specialist as part of routine medical care.
- Subject must be willing to postpone starting medication until after completion of baseline assessment(s).
Key exclusion criteria (7 listed)
- Any change to medication(s) within the last 45 days
- History of chronic alcohol or drug abuse within the prior 12 months
- Heart failure, history of severe hypertension, or other cardiovascular disease compromising the patient's wellbeing or ability to participate in this study
- Use of any sleep apnea treatment (e.g., Positive Airway Pressure (PAP) therapy, oral appliance therapy, etc.) within 45 days of baseline assessment visit
- Participation in another study of an investigational drug within the 28 days prior to screening visit or currently
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 |
|---|---|---|
| 24-hour Ambulatory Blood Pressure MonitoringAlso: Actigraphy, Sleep diaryArm blood pressure cuff that will automatically inflate every 15-30 minutes to check blood pressure while awake and asleep over 24 hours. Patient will also complete a sleep diary and wear an actigraphy watch during this test. | Diagnostic test | Idiopathic Hypersomnia, Narcolepsy Type 1, Narcolepsy Type 2 |
| Oculo-Cognitive Addition Test (OCAT)Tracks users' eye movements as they complete a simple mental addition test. | Diagnostic test | Idiopathic Hypersomnia, Narcolepsy Type 1, Narcolepsy Type 2 |
Primary outcome
Change in mean 24-hour ambulatory blood pressure
Time frame: Baseline, at least 3 months
Change in 24-hour ambulatory blood pressure from baseline (pre-treatment) to after taking a stable dose of medication for at least 3 months
3 secondary outcomes
Change in Oculo-Cognitive Addition Test (OCAT) completion time
Time frame: Baseline, at least 3 months
Change in mean daytime and nighttime 24-hour ambulatory blood pressure
Time frame: Baseline, at least 3 months
Change in 24-hour ambulatory blood pressure diurnal pattern (dipper versus non-dipper)
Time frame: Baseline, at least 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- 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.
Chad Ruoff, MD principal investigator
Mayo Clinic
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 Idiopathic Hypersomnia, run by Mayo Clinic 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 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: enrolling by invitation, as of the sponsor's last update on 9 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in mean 24-hour ambulatory blood pressure (time frame: Baseline, at least 3 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 9 Jun 2026.