A clinical trial is any research study that evaluates interventions to prevent, detect, diagnosis, or treat a disease or disorder. In a clinical trial, human participants (or groups of participants) are assigned to one or more interventions to assess the results on health outcomes.
Why Are Clinical Trials Important?
Clinical Trials are important in discovering new treatments to prevent, detect, diagnosis, or treat narcolepsy. It is the only process to bring new pharmacological drugs and treatments forward for approval to use within the narcolepsy community. Without the clinical trials, there is a risk that individuals could be given treatments which have no advantage, waste time, and could even be harmful to one’s health. If a treatment has no benefit, or has serious side effects, the treatment may not be further developed.
Ongoing Research
Canadian Sleep Society: Recruitment of 1000 Families of Children Who Experience Sleeping Problems
Scaling-out Better Nights, Better Days
to help children and families go from surviving to thriving during COVID-19.
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Better Nights, Better Days is an evidence-based eHealth program to support parents of typically developing children ages 1-10 years old who experience sleeping problems including difficulties falling asleep, staying asleep, and waking too early.
The national team of investigators are conducting this study to understand if Better Nights, Better Days improves the sleep, mental health, wellbeing, and family resiliency in children and parents during the COVID-19 pandemic, and test how to scale-out the Better Nights, Better Days program to support families across Canada.
We are recruiting 1000 families of children who experience sleeping problems to test the clinical effectiveness of Better Nights, Better Days during COVID-19 and evaluate the implementation of the program to scale-out Better Nights, Better Days across Canada. There is no cost for families to participate.
Inclusion Criteria
- Parent of a child is between the ages of 1 and 10 years old
- Family resides in Canada
- Parent has regular access to high-speed internet and email
- Parent can read, write, and understand English
- Child experiences behavioural sleep difficulties (i.e., problems falling asleep or falling asleep independently; problems following bedtime routines or bedtime resistance; problems staying asleep)
Please share this information with families who you feel may benefit from participating.
This study is being funded by the Canadian Institutes of Health Research (CIHR) Operating Grant: COVID-19 Mental Health & Substance Use Service Needs and Delivery, led by Dr. Penny Corkum (Dalhousie University, IWK Health Centre).
RESTORE
** Find participating sites at ClinicalTrials.gov NCT#: NCT04451668
If you or your child are over 16 and have been diagnosed with narcolepsy, you may qualify for a research study.
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If you or your child are over 16 and have been diagnosed with narcolepsy, you may qualify for a research study.
Managing your narcolepsy symptoms is challenging, so learning all your treatment options is very important. One option to consider is the RESTORE study of an investigational medicine, FT218, which is a once‐nightly formulation of sodium oxybate.
In this study, FT218 will be taken orally once per night, before you go to bed, for up to two years. You’ll be asked to complete in‐person or virtual study visits about four times per year and also complete some brief questionnaires.
Who is eligible to participate in this study?
To qualify, you or your child must:
• Be 16 years of age or older
• Be diagnosed with narcolepsy with or without cataplexy
• Have completed the REST‐ON Study and/or be receiving twice‐nightly sodium oxybate
** Find participating sites at ClinicalTrials.gov NCT#:NCT04451668**
Tenor Study
Find out if you are eligible for this online research study documenting the transition from Xyrem to Xywav.
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The Transition Experience of persons with Narcolepsy taking Oxybate in the Real-world (TENOR) study is enrolling individuals with narcolepsy who are transitioning from Xyrem to Xywav within the previous or upcoming 7 days. This study is entirely virtual and was designed with the help of a patient advisory board and input from board-certified sleep physicians who specialize in narcolepsy. If you take part in the study, you may help patients, doctors, and researchers better understand how narcolepsy treatments affect people with narcolepsy. As a part of your participation, you will receive reports summarizing your self-reported data throughout the study. At the end of the study, you will receive a consolidated report of your personal data.
Visit www.tenorstudy.com to learn more or review the attached brochure.
Hypersomnia and Narcolepsy Study is Recruiting Participants
There is a new clinical trial opportunity for PWNs located in Canada.
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There is a new clinical trial opportunity for PWNs located in Canada.
To be eligible to participate, you must meet the following criteria:
- Diagnosed with narcolepsy and/or idiopathic hypersomnia
- Age between 18-64
- Living in Canada
- Ability to travel to Montreal
- Have no other sleep disorders
- Have no psychiatric or neurological disorders
- Not pregnant or breastfeeding
- No use of psychotropic drugs
- Eligible for an MRI scan (no pacemaker or metallic prosthesis)
Compensation will be offered for participation. To apply please contact: hypersomnia.research@gmail.com
Do daytime “sleep attacks” leave you dreaming about a better treatment for narcolepsy?
SUVN‑G3031 study: Clinical Trial Listing
Do you have excessive daytime sleepiness from narcolepsy? You may be interested to learn about SUVN-G3031, a research study evaluating an investigational product for narcolepsy with and without cataplexy.
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Do daytime “sleep attacks” leave you dreaming about a better treatment for narcolepsy?
Do you have excessive daytime sleepiness from narcolepsy? You may be interested to learn about SUVN-G3031, a research study evaluating an investigational product for narcolepsy with and without cataplexy. Currently, there are treatments available that can increase alertness and improve daytime performance in people with narcolepsy. There are also treatments available to help improve the effects of cataplexy. Doctors continue to research treatments through clinical studies because a single safe and effective treatment for multiple symptoms is still unavailable.
The main purpose of this study is to learn how well the study drug works and how safe the study drug is compared to placebo. A placebo is an inactive material that looks like the study drug but does not contain any active study drug.
What will happen in this study?
If you are eligible to enroll in this study, you will be in this study for approximately 7 weeks, and you will need to come to the study center at least 5 times over this period. You will take either the study drug tablet or a placebo tablet once every day for 14 days. You will stay overnight at the study clinic 3 times for a sleep study and other study procedures. You will also come to the study clinic for a safety follow-up visit.
Who is eligible to participate in this study?
To be eligible for this study, you must be:
- Be between 18 and 50 years of age
- Have a diagnosis of narcolepsy confirmed by a sleep study
This is not a complete list of study requirements. The study doctor will review the full requirements for this study with you.
Qualified participants will receive all study-related exams, care and medications at no cost. Compensation for time and travel may be available.
If you are interested in learning more, visit https://narcolepsyclinicalstudy.com/WUN/
Recruiting Participants with Excessive Sleepiness
WUN is collaborating with Hypersomnia Foundation and Dr. Thanh Dang-Vu to investigate brain regions underlying narcolepsy (with or without cataplexy) and idiopathic hypersomnia.
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Who can participate: We are looking for patients 18 years or more who have been diagnosed with Narcolepsy (with or without cataplexy) or Idiopathic Hypersomnia.
What are the factors that may exclude you from participating? 1- Other sleep disorders, 2- Neurological disorders or head trauma, 3-Psychiatric disorders or use of psychotropic drugs, 4- Pregnancy or breastfeeding and 5-Pacemaker or metallic prosthesis
What will participants have to do? To investigate brain regions underlying narcolepsy (with or without cataplexy) and idiopathic hypersomnia. This study includes two (non- consecutive) overnight sleep sessions at the sleep laboratory and a MRI scan session. Participants will have to travel to Montreal.
If you are interested by this study, please contact: Elizaveta Frolova, research coordinator. Email: hypersomnia.research@gmail.com
