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Low Sodium Oxybate in Patients With Idiopathic Hypersomnia

Primary Purpose

Idiopathic Hypersomnia

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Low Sodium Oxybate
24-hour polysomnography
Nextsense EEG earbuds
Axivity device
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Hypersomnia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 ≥ 10 hours most days including daytime naps/sleep based upon at least 10/14 days of completed sleep diary entries Epworth Sleepiness Scale (ESS) ≥ 10 (required at pre-screening visit only) Recommended LSO by a clinical sleep specialist as part of routine medical care. The clinical sleep specialist will be responsible for titrating LSO according to standard of care. Subject must be willing to postpone LSO therapy until all baseline assessments completed If treated with wake promoting agents, traditional stimulants and/or antidepressant(s), a stable dose and regimen will be required for at least 2 months before study entry and throughout the main study Have used a medically acceptable method of contraception for at least 2 full menstrual cycles before participating in this study and consent to use a medically acceptable method of contraception from the first dose of study drug, throughout the entire study period, and for 30 days after the last dose of study drug. Exclusion Criteria: 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 History of chronic alcohol or drug abuse within the prior 12 months Malignant neoplastic disease requiring therapy within the prior 12 months Heart failure, severe hypertension or other cardiovascular disease compromising the patient's well-being or ability to participate in this study Renal or hepatic impairment Compromised respiratory function (e.g., history of COPD, pulmonary hypertension, and/or poorly controlled asthma) Diagnosis of sleep-related breathing disorders (AHI ≥ 15 events/h using 4 % AHI) or high suspicion for sleep disordered breathing Any sleep apnea treatment (e.g., Positive Airway Pressure (PAP) therapy, oral appliance therapy, etc.) No regular sleep at night: shift work or other continuous, non-disease-related life conditions Participation in another study of an investigational drug within the 28 days prior to Screening visit or currently Pregnant and/or breast-feeding Ear jewelry and/or piercings that subject not willing to/unable to remove Use of device/implant that may interfere with the study devices/procedures (e.g., vagal nerve stimulator) Smoke and/or use of smokeless tobacco products Subjects who, in the opinion of the investigator(s), may not be suitable for the study

Sites / Locations

  • Mayo Clinic ArizonaRecruiting
  • Stanford University
  • Mayo Clinic Florida
  • Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Low Soduim Oxybate for Idiopathic Hypersomnia

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in Total Sleep Time
Measured by the 24-hour polysomnography reported as total minutes a participant is deemed sleeping.

Secondary Outcome Measures

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.
Change in total sleep time as measured by Axivity device
Measured by the Axivity device reported as total minutes a participant is deemed sleeping.
Change in total sleep time as measured by patient sleep diary
Measured by patient sleep diary entries as total minutes a participant reported sleeping.

Full Information

First Posted
April 19, 2023
Last Updated
October 2, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT05837091
Brief Title
Low Sodium Oxybate in Patients With Idiopathic Hypersomnia
Official Title
Impact of Low Sodium Oxybate on Total Sleep Time in Patients With Idiopathic Hypersomnia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Hypersomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low Soduim Oxybate for Idiopathic Hypersomnia
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Low Sodium Oxybate
Other Intervention Name(s)
Xywav, Calcium, Magnesium, Potassium, and Sodium Oxybates
Intervention Description
Titrated according to standard of care and continued on stable dose for 3 months
Intervention Type
Diagnostic Test
Intervention Name(s)
24-hour polysomnography
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Nextsense EEG earbuds
Intervention Description
Ear buds used to record sleep staging worn for a 24-hours period
Intervention Type
Device
Intervention Name(s)
Axivity device
Intervention Description
Wristband that records activity level worn for approximately one month to track sleep and steps/activity.
Primary Outcome Measure Information:
Title
Change in Total Sleep Time
Description
Measured by the 24-hour polysomnography reported as total minutes a participant is deemed sleeping.
Time Frame
Baseline, 3 months
Secondary Outcome Measure Information:
Title
Change in total sleep time as measured by Nextsense EEG earbuds
Description
Measured by the Nextsense EEG earbuds reported as total minutes a participant is deemed sleeping.
Time Frame
Baseline, 3 months
Title
Change in total sleep time as measured by Axivity device
Description
Measured by the Axivity device reported as total minutes a participant is deemed sleeping.
Time Frame
Baseline, 3 months
Title
Change in total sleep time as measured by patient sleep diary
Description
Measured by patient sleep diary entries as total minutes a participant reported sleeping.
Time Frame
Baseline, 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 ≥ 10 hours most days including daytime naps/sleep based upon at least 10/14 days of completed sleep diary entries Epworth Sleepiness Scale (ESS) ≥ 10 (required at pre-screening visit only) Recommended LSO by a clinical sleep specialist as part of routine medical care. The clinical sleep specialist will be responsible for titrating LSO according to standard of care. Subject must be willing to postpone LSO therapy until all baseline assessments completed If treated with wake promoting agents, traditional stimulants and/or antidepressant(s), a stable dose and regimen will be required for at least 2 months before study entry and throughout the main study Have used a medically acceptable method of contraception for at least 2 full menstrual cycles before participating in this study and consent to use a medically acceptable method of contraception from the first dose of study drug, throughout the entire study period, and for 30 days after the last dose of study drug. Exclusion Criteria: 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 History of chronic alcohol or drug abuse within the prior 12 months Malignant neoplastic disease requiring therapy within the prior 12 months Heart failure, severe hypertension or other cardiovascular disease compromising the patient's well-being or ability to participate in this study Renal or hepatic impairment Compromised respiratory function (e.g., history of COPD, pulmonary hypertension, and/or poorly controlled asthma) Diagnosis of sleep-related breathing disorders (AHI ≥ 15 events/h using 4 % AHI) or high suspicion for sleep disordered breathing Any sleep apnea treatment (e.g., Positive Airway Pressure (PAP) therapy, oral appliance therapy, etc.) No regular sleep at night: shift work or other continuous, non-disease-related life conditions Participation in another study of an investigational drug within the 28 days prior to Screening visit or currently Pregnant and/or breast-feeding Ear jewelry and/or piercings that subject not willing to/unable to remove Use of device/implant that may interfere with the study devices/procedures (e.g., vagal nerve stimulator) Smoke and/or use of smokeless tobacco products Subjects who, in the opinion of the investigator(s), may not be suitable for the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lupe (Ray) Canez
Phone
(480)-574-2753
Email
Canez.Lupe@mayo.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Arleth Valencia
Email
Valencia.Arleth@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chad Ruoff, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lupe (Ray) Canez
Phone
480-574-2753
Email
Canez.Lupe@mayo.edu
First Name & Middle Initial & Last Name & Degree
Chad Ruoff, MD
Facility Name
Stanford University
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miran Cho
Phone
650-497-8690
Email
mirancho@stanford.edu
First Name & Middle Initial & Last Name & Degree
Emmanuel Mignot, MD
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Chang
Phone
904-953-4637
Email
chang.caroline@mayo.edu
First Name & Middle Initial & Last Name & Degree
Joseph Cheung, MD
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Phoebe Aney
Phone
617-975-7568
Email
paney@bidmc.harvard.edu
First Name & Middle Initial & Last Name & Degree
Robert Thomas, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Low Sodium Oxybate in Patients With Idiopathic Hypersomnia

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