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 States59 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 range18 Years – 65 Years
SexALL
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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:
✓. 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.
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)
. 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.