Health TrialsbyHealthPanel

Low Sodium Oxybate in Patients With Idiopathic Hypersomnia

ConditionIdiopathic Hypersomnia
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Primary diagnosis of IH, according to ICSD-3 criteria (does not require MSLT)

Subjects aged 18 - 65 years

BMI between 18 and 35 kg/m2

Self-reported sleep duration ≥ 9 hours most days including daytime naps/sleep based upon at least 10/14 days of completed sleep diary entries

Disqualifiers

Succinic semialdehyde dehydrogenase deficiency, porphyria

Other central nervous system diseases: neurodegenerative diseases, , seizure disorders or history of head trauma associated with loss of consciousness

Lifetime history of suicide attempt or suicidal ideation in the past six months, including answer to question #9 on PHQ-9 ≥1; PHQ-9 total score > 10; prior history of psychotic episodes; active major depressive disorder

Change to psychiatric medication(s)/stimulant(s) within last 3 months

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Low Soduim Oxybate for Idiopathic HypersomniaExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Change in Total Sleep Time

Measured by the 24-hour polysomnography reported as total minutes a participant is deemed sleeping.

Time frame
Baseline, 3 months

Secondary outcomes

1

Change in total sleep time as measured by Nextsense EEG earbuds

Measured by the Nextsense EEG earbuds reported as total minutes a participant is deemed sleeping.

Time frame
Baseline, 3 months
2

Change in total sleep time as measured by Axivity device

Measured by the Axivity device reported as total minutes a participant is deemed sleeping.

Time frame
Baseline, 3 months
3

Change in total sleep time as measured by patient sleep diary

Measured by patient sleep diary entries as total minutes a participant reported sleeping.

Time frame
Baseline, 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
Apply now