SHARP
Trial question
What is the role of solriamfetol, an NDRI, in patients with cognitive impairment associated with obstructive sleep apnea and excessive daytime sleepiness?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
36.0% female
64.0% male
N = 59
59 patients (21 female, 38 male).
Inclusion criteria: patients with cognitive impairment associated with obstructive sleep apnea and excessive daytime sleepiness.
Key exclusion criteria: usual bedtime later than 1:00 am; shift work; use of medications that could affect excessive daytime sleepiness; contraindication for solriamfetol; use of positive airway pressure machine without downloadable adherence data; sleep disorder other than obstructive sleep apnea; excessive caffeine use; clinically relevant medical, behavioral, or psychiatric disorder associated with impaired cognitive function.
Interventions
N=30 solriamfetol (75 mg daily for 3 days, then 150 mg daily for 2 weeks).
N=29 placebo (matching placebo each morning for 2 weeks).
Primary outcome
Improvement in postdose average Digit Symbol Substitution Test of Repeatable Battery for the Assessment of Neuropsychological Status scores
6.49 points
4.74 points
6.5 points
4.9 points
3.2 points
1.6 points
0.0 points
Solriamfetol
Placebo
Significant
increase ▲
Significantly greater improvement in postdose average Digit Symbol Substitution Test of the Repeatable Battery for the Assessment of Neuropsychological Status scores (6.49 points vs. 4.74 points; MD 1.75, 95% CI 0.46 to 3.04).
Secondary outcomes
Significantly greater reduction in British Columbia Cognitive Complaints Inventory score (4.7 points vs. 3.1 points; MD 1.58, 95% CI 0.63 to 2.53).
Significantly greater reduction in Patient Global Impression of Severity score (0.9 points vs. 0.61 points; MD 0.29, 95% CI 0.02 to 0.57).
Significantly greater reduction in Epworth Sleepiness Scale score (4.41 points vs. 2.31 points; MD 2.1, 95% CI 0.68 to 3.51).
Safety outcomes
No significant difference in treatment-emergent adverse events.
Conclusion
In patients with cognitive impairment associated with obstructive sleep apnea and excessive daytime sleepiness, solriamfetol was superior to placebo with respect to improvement in postdose average Digit Symbol Substitution Test of the Repeatable Battery for the Assessment of Neuropsychological Status scores.
Reference
Hans P A Van Dongen, Eileen B Leary, Christopher Drake et al. Results of the Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-Controlled Study (SHARP): 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 OSA With Excessive Daytime Sleepiness and Cognitive Impairment. Chest. 2025 Mar;167(3):863-875.
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