Low Sodium Oxybate in Patients With Idiopathic Hypersomnia

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT05837091
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Idiopathic Hypersomnia

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Low Sodium Oxybate — DRUG
    Titrated according to standard of care and continued on stable dose for 3 months
  • 24-hour polysomnography — DIAGNOSTIC_TEST
    Performed in a sleep study lab, recording of body functions including brain activity, eye movements, muscle activity, heart rhythm and blood oxygen levels while asleep and awake for a 24-hour period
  • Nextsense EEG earbuds — DEVICE
    Ear buds used to record sleep staging worn for a 24-hours period
  • Axivity device — DEVICE
    Wristband that records activity level worn for approximately one month to track sleep and steps/activity.

Study Details

Low sodium oxybate has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of idiopathic hypersomnia. In this study, the researchers want to learn how low sodium oxybate impacts ability of people diagnosed with idiopathic hypersomnia to sleep for long periods of time. In addition, this study will use novel tools to determine when an individual is awake or asleep.

Key Dates

Start date
Feb 14, 2024
Status verified
Apr 2026
Primary completion
Jan 29, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Low Soduim Oxybate for Idiopathic Hypersomnia
    Subjects prescribed with low sodium oxybate for idopathic hypersomnia will have a 24-hour polysomnography, wear an Axivity wristband and Nextsense EEG earbuds to evaluate total sleep time.

Primary Outcome Measure

Change in Total Sleep Time [ Time Frame: Baseline, 3 months ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Mayo Clinic ArizonaPhoenixArizona85054
Lupe (Ray) Canez
[email protected]
(480) 574-2753
Chad Ruoff, MD (PRINCIPAL_INVESTIGATOR)
Stanford UniversityRedwood CityCalifornia94063
Miran Cho
[email protected]
(650)503-3489
Emmanuel Mignot, MD (PRINCIPAL_INVESTIGATOR)
Oliver Sum-Ping, MD (SUB_INVESTIGATOR)
Mayo Clinic FloridaJacksonvilleFlorida32224
Wesley Dillinger
[email protected]
(904)953-3626
Joseph Cheung, MD (PRINCIPAL_INVESTIGATOR)
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Phoebe Aney
[email protected]
(617) 975-7568
Robert Thomas, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Mayo Clinic Arizona· Phoenix, AZStanford University· Redwood City, CAMayo Clinic Florida· Jacksonville, FLBeth Israel Deaconess Medical Center· Boston, MA

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