Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-contr… (NCT04789174) | Clinical Trial Compass
CompletedPhase 4
Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled Study
United States, Canada, Italy59 participantsStarted 2021-05-17
Plain-language summary
The purpose of study JZP110-405 is to determine whether solriamfetol is effective at improving cognitive function in participants with excessive daytime sleepiness (EDS) associated with obstructive sleep apnea (OSA) plus impaired cognitive function.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female between 18 (or the legal age of consent in the jurisdiction in which the study takes place) and 65 years of age, inclusive.
. Diagnosis of OSA according to International Classification of Sleep Disorders, Third Edition criteria.
. Participant report (with clinician concurrence) of at least 1 of the following primary OSA therapy criteria:
. Usual nightly total sleep time of ≥ 6 hours.
. Body mass index from 18.5 to \< 40 kg/m2.
. Male participants are eligible to participate if they agree to the following during the study intervention period and for at least 14 days after the last dose of study intervention:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline in the Average of the DSST RBANS Scores at the End of Each Double-blind Treatment Period
Timeframe: Baseline to the end of the second double-blind treatment period (up to 5 weeks)
. A female participant is eligible to participate if she is not pregnant or breastfeeding, and 1 of the following conditions applies:
. Capable of giving signed informed consent.
Exclusion criteria
. Female participants who are pregnant, nursing, or lactating.
. Usual bedtime later than 1 AM (0100 hours).
. Occupation requiring nighttime or variable shift work.
. Unable to understand or perform DSST test per investigator's judgement.
. Use a PAP machine with no adherence data downloadable ability.
. Diagnosis of another sleep disorder (other than OSA) including: circadian rhythm sleep disorders, narcolepsy, restless legs syndrome determined by participant sleep history.
. Presence of acutely unstable major depression or current major depressive episode as based on the judgement of the investigator.
. Participants with active clinically significant illness, including endocrine, neoplastic, gastrointestinal, hematological, hepatic, immunologic, metabolic, neurological, pulmonary, and/or renal disease, and/or surgical history which could interfere with the study efficacy, safety, conduct or the ability of the participant to complete the study based on the judgement of the investigator, or place the participant at risk during the trial or compromise the study objectives.