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Central Nervous System Depressant
Low Sodium Oxybate for Idiopathic Hypersomnia
Phase 4
Recruiting
Led By Chad Ruoff, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects aged 18 - 65 years
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months
Awards & highlights
Study Summary
This trial will study how low sodium oxybate impacts sleep quality & duration in people with idiopathic hypersomnia using new tools to monitor sleep.
Who is the study for?
This trial is for adults aged 18-65 with idiopathic hypersomnia, who often sleep over 10 hours daily including naps. They must be recommended low sodium oxybate by a sleep specialist and agree to use contraception. Exclusions include certain medical conditions like seizure disorders, recent drug abuse, or severe cardiovascular issues.Check my eligibility
What is being tested?
Researchers are testing the effects of low sodium oxybate on people with idiopathic hypersomnia using novel monitoring tools like polysomnography, EEG earbuds, and an Axivity device to track sleep patterns and wakefulness.See study design
What are the potential side effects?
While not explicitly listed in the provided information, common side effects of low sodium oxybate may include dizziness, nausea, headache, confusion, bedwetting and less commonly breathing problems or mood changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
Select...
I have been on a stable dose of medication for sleep or mood for at least 2 months.
Select...
I have been diagnosed with Idiopathic Hypersomnia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Total Sleep Time
Secondary outcome measures
Change in total sleep time as measured by Axivity device
Change in total sleep time as measured by Nextsense EEG earbuds
Change in total sleep time as measured by patient sleep diary
Trial Design
1Treatment groups
Experimental Treatment
Group I: Low Soduim Oxybate for Idiopathic HypersomniaExperimental Treatment4 Interventions
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.
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,216 Previous Clinical Trials
3,767,458 Total Patients Enrolled
1 Trials studying Idiopathic Hypersomnia
100 Patients Enrolled for Idiopathic Hypersomnia
Chad Ruoff, MDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
100 Total Patients Enrolled
1 Trials studying Idiopathic Hypersomnia
100 Patients Enrolled for Idiopathic Hypersomnia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have kidney or liver problems.I have needed treatment for cancer within the last year.A sleep specialist recommended I use a sleep orthosis as part of my treatment.Your Epworth Sleepiness Scale score is 10 or higher.I do not have severe heart or blood pressure problems that would stop me from joining this study.You scored 10 or higher on the Epworth Sleepiness Scale.I haven't changed my psychiatric or stimulant medications in the last 3 months.I am receiving treatment for sleep apnea.You smoke or use smokeless tobacco products.I am between 18 and 65 years old.You sleep for at least 10 hours most days, including naps, based on your sleep diary entries for at least 10 out of 14 days.Your body mass index (BMI) is between 18 and 35.I have a lung condition like COPD, asthma, or pulmonary hypertension.I have been diagnosed with a severe sleep breathing disorder.I cannot or will not remove my ear jewelry/piercings.You have recently had thoughts of hurting yourself or have a history of severe depression or mental illness.I have a history of brain-related conditions, like seizures or severe head injuries.I have been on a stable dose of medication for sleep or mood for at least 2 months.I have a rare genetic disorder affecting my metabolism.You have had problems with drinking alcohol or using drugs regularly in the past year.I have been diagnosed with Idiopathic Hypersomnia.You don't have a regular sleep schedule at night due to working night shifts or other non-health related reasons.
Research Study Groups:
This trial has the following groups:- Group 1: Low Soduim Oxybate for Idiopathic Hypersomnia
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Idiopathic Hypersomnia Patient Testimony for trial: Trial Name: NCT05837091 — Phase 4
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals of advanced age being considered for inclusion in this research?
"In order to meet the stipulated criteria for enrolment, potential participants must be aged between 18 and 65."
Answered by AI
Could you please elucidate the degree of security associated with Low Soduim Oxybate in patients suffering from Idiopathic Hypersomnia?
"The safety of Low Sodium Oxybate for Idiopathic hypersomnia has been established, as the trial is in its fourth phase. Thus, it received a rating of 3 on our scale at Power."
Answered by AI
How many locations have implemented this research endeavor?
"Currently, the 4 centres taking part in this trial are Stanford University (Redwood City), Mayo Clinic Florida (Jacksonville), Beth Israel Deaconess Medical Center (Boston). Additionally, there are an additional four locations."
Answered by AI
Are there any vacancies left for individuals to take part in this trial?
"This protocol is not currently recruiting, as per the data on clinicaltrials.gov which last updated this trial on April 19th 2023; however, there are presently twenty other trials actively searching for participants."
Answered by AI
Does my profile qualify me to partake in this research endeavor?
"To join this medical trial, prospective participants must have idiopathic hypersomnia and be between 18-65 years old. Approximately 30 people are needed for the study."
Answered by AI
Who else is applying?
What state do they live in?
Rhode Island
What site did they apply to?
Beth Israel Deaconess Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
What questions have other patients asked about this trial?
Would it be possible to do this in summer 2024? I work at a school but am off work from the middle of June to the end of August. Also, where does the trial take place - e.g., would I be a the medical facility for 3 weeks for screening, or would I have to come in for an appointment every day?
PatientReceived 2+ prior treatments
Why did patients apply to this trial?
I’m hopeful that these clinical trials will help other patients with IH.
PatientReceived 1 prior treatment
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