Phase 4 Sleep Disorders Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with Idiopathic Hypersomnia (a condition causing excessive sleepiness) based on recognised medical guidelines
• People aged between 18 and 65 years
• People whose body mass index (a measure of body weight relative to height) falls between 18 and 35
• People who report sleeping 9 or more hours most days (including daytime naps), with at least 10 out of 14 days recorded in a sleep diary to confirm this
• People who score 10 or higher on the Epworth Sleepiness Scale (a standard questionnaire measuring daytime sleepiness) at the initial screening visit
• People whose sleep specialist has recommended a treatment called Luminate Sleep Optimizer (LSO) as part of their regular medical care
• People who are willing to wait until all baseline assessments are completed before starting LSO treatment
• People already taking medications to promote wakefulness or treat depression who have been on a stable dose for at least 2 months before joining and throughout the main part of the study
• People who have been using a medically accepted form of contraception for at least two full menstrual cycles before joining, and who agree to continue using contraception throughout the study and for 30 days after the last dose of study medication

Who may not be able to join:

• People with certain rare metabolic or blood disorders, including succinic semialdehyde dehydrogenase deficiency or porphyria
• People with other brain or nervous system conditions, such as neurodegenerative diseases, seizure disorders, or a history of head injury that caused loss of consciousness
• People with a lifetime history of a suicide attempt, suicidal thoughts in the past six months, a history of psychotic episodes, or a current diagnosis of major depression (including specific scores on a standard depression questionnaire)
• People who have had a change to their psychiatric medications or stimulants within the last 3 months
• People with a history of ongoing alcohol or drug misuse within the past 12 months
• People who have required treatment for cancer within the past 12 months
• People with heart failure, severely high blood pressure, or other heart or cardiovascular conditions that could affect their health or ability to take part
• People with kidney or liver problems
• People with significant breathing problems, such as chronic obstructive pulmonary disease (a lung condition), high blood pressure in the lungs, or poorly controlled asthma
• People diagnosed with a sleep-related breathing disorder such as moderate-to-severe sleep apnoea, or where sleep apnoea is strongly suspected
• People currently using any treatment for sleep apnoea, such as a CPAP machine or a dental device
• People who do not have a regular night-time sleep schedule due to shift work or similar ongoing lifestyle circumstances
• People who have taken part in another clinical drug trial within the 28 days before the screening visit, or who are currently in another trial
• People who are pregnant or breastfeeding
• People who have ear jewellery or piercings that they are unwilling or unable to remove
• People who use a device or implant that could interfere with the study equipment, such as a vagal nerve stimulator (confirm with trial site)
• People who smoke or use any smokeless tobacco products
• People whom the study investigators consider unsuitable for the trial for any reason

Important: Always verify eligibility with the trial site directly before applying.