Results of the SHARP Study: A Randomized, Placebo-Controlled, Double-Blind, Repeated-Measures, Crossover, Phase IV Clinical Trial of the Effect of the Wake-Promoting Agent Solriamfetol on Cognitive Function in Obstructive Sleep Apnea With Excessive Daytime Sleepiness and Cognitive Impairment
Abstract
BACKGROUND
Obstructive sleep apnea (OSA) causes episodes of fragmented sleep and intermittent hypoxia and leads to excessive daytime sleepiness (EDS). Deficits in cognitive function are a troublesome symptom in patients with OSA and EDS.
RESEARCH QUESTION
How does solriamfetol affect cognitive function in patients with cognitive impairment associated with OSA and EDS?
STUDY DESIGN AND METHODS
SHARP was a phase 4, randomized, double-blind, placebo-controlled, crossover trial. Participants (N=59) were randomized to receive placebo or solriamfetol (75 mg/day for 3 days, then 150 mg/day) for 2 weeks, with crossover separated by a 1-week washout. Efficacy measures included the Coding subtest, comparable to the Digit Symbol Substitution Test, of the Repeatable Battery for the Assessment of Neuropsychological Status (DSST RBANS), the British Columbia Cognitive Complaints Inventory (BC-CCI), Patient Global Impression of Severity (PGI-S), and Epworth Sleepiness Scale (ESS). The primary endpoint was change from baseline in average post-dose DSST RBANS scores. Secondary endpoints were changes from baseline in BC-CCI, PGI-S, ESS, and DSST RBANS scores at 2, 4, 6, and 8 hours post-dose. Safety was monitored by treatment-emergent adverse events (TEAEs).
RESULTS
Solriamfetol significantly improved post-dose average DSST RBANS scores compared with placebo (P=0.009; effect size [Cohen's d] 0.37). When evaluated at each 2-hour timepoint, cognitive function was significantly improved at 2, 6,…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 59 participants or records.
Read the paper
Related studies
- The Matrisome: In Silico Definition and In Vivo Characterization by Proteomics of Normal and Tumor Extracellular Matrices
- The Escherichia coli MG1655 in silico metabolic genotype: Its definition, characteristics, and capabilities
- In silico pharmacology for drug discovery: methods for virtual ligand screening and profiling
- In silico prediction of splice-altering single nucleotide variants in the human genome
- In silico clinical trials: how computer simulation will transform the biomedical industry
- In silico optimization of a guava antimicrobial peptide enables combinatorial exploration for peptide design
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.