Abstract Details

Title Effects of Solriamfetol on Cognitive Function in Participants with Cognitive Impairment Associated with Excessive Daytime Sleepiness in Obstructive Sleep Apnea: Results of the SHARP Study

Topic Sleep

Presentation(s) P4 - Poster Session 4 (8:00 AM-9:00 AM)

Poster/Presentation
Number 11-004

Objective The SHARP study evaluated whether solriamfetol improves cognitive function in patients with excessive daytime sleepiness (EDS) associated with obstructive sleep apnea (OSA) and extant impaired cognition.

Background OSA is a common disorder characterized by repeated intermittent hypoxic events resulting in disrupted sleep and EDS. Positive Airway Pressure (PAP) reduces hypoxic events and mitigates sleep disruption, but EDS often persists. Cognitive impairment is a burdensome symptom in many patients with EDS associated with OSA, which leads to occupational and social dysfunction and degrades quality of life. Solriamfetol (Sunosi®) is approved to improve wakefulness in adults with EDS associated with OSA. In nonclinical pharmacology studies, solriamfetol inhibited dopamine/norepinephrine reuptake and activated trace amine-associated receptor 1 (TAAR1), potentially benefiting cognition.

Design/Methods SHARP was a randomized, double-blind, placebo-controlled, crossover trial in 59 patients with EDS associated with OSA and demonstrated cognitive impairment. All patients received solriamfetol (75mg for 3 days followed by 150mg/day) for 2 weeks, and placebo for 2 weeks, with treatment periods separated by a 1-week washout. The primary endpoint was change from baseline on the Digit Symbol Substitution Test equivalent of the Repeatable Battery for the Assessment of Neuropsychological Status (DSST-RBANS). Secondary endpoints included change from baseline on the British Columbia Cognitive Complaints Inventory (BC-CCI) and the Epworth Sleepiness Scale (ESS).

Results

The study completion rate was 96.7%. Solriamfetol treatment improved performance on the DSST-RBANS compared to placebo (6.49 vs. 4.75, p=0.009), with an effect size (Cohen’s d) of 0.36. Solriamfetol treatment also yielded improvements on the BC-CCI (-4.70 vs -3.11, p=0.002; d =0.43) and the ESS (-4.41 vs -2.31, p=0.004; d = 0.50). The most common adverse events with solriamfetol treatment (incidence ≥3%) were nausea (6.9%) and anxiety (3.4%).

Conclusions Solriamfetol (150mg/day) improved both objective and subjective measures of cognitive function in patients with EDS associated with OSA and impaired cognition.

Authors/Disclosures
Eileen Leary, PhD (Axsome Therapeutics) PRESENTER	Dr. Leary has received personal compensation for serving as an employee of Centessa Pharmaceuticals. Dr. Leary has received personal compensation for serving as an employee of Axsome Therapeutics. Dr. Leary has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Clinical Partners Group. Dr. Leary has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Pulse Infoframe. Dr. Leary has or had stock in Jazz Pharmaceuticals.Dr. Leary has or had stock in Axsome Therapeutics.Dr. Leary has or had stock in Centessa Pharmaceuticals.
Hans Van Dongen (Washington State University)	Hans Van Dongen has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Jazz Pharmaceuticals. Hans Van Dongen has received intellectual property interests from a discovery or technology relating to health care. Hans Van Dongen has received publishing royalties from a publication relating to health care.
	No disclosure on file
Richard K. Bogan, MD (SleepMed)	Dr. Bogan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Jazz Pharmaceutical . Dr. Bogan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Takeda. Dr. Bogan has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Axsome . Dr. Bogan has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Harmony. Dr. Bogan has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Jazz. Dr. Bogan has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Axsome. Dr. Bogan has received personal compensation in the range of $50,000-$99,999 for serving as an Expert Witness for Jazz. The institution of Dr. Bogan has received research support from Jazz Pharmaceuticals. The institution of Dr. Bogan has received research support from Harmony . The institution of Dr. Bogan has received research support from Eisai. The institution of Dr. Bogan has received research support from Avadel. The institution of Dr. Bogan has received research support from Takeda. The institution of Dr. Bogan has received research support from Suven. The institution of Dr. Bogan has received research support from Axsome. The institution of Dr. Bogan has received research support from Merck. The institution of Dr. Bogan has received research support from Liva Nova. The institution of Dr. Bogan has received research support from Nyxoah. Dr. Bogan has received research support from Bayer. Dr. Bogan has received intellectual property interests from a discovery or technology relating to health care.
	No disclosure on file
Russell Rosenberg (Neurotrials Research)	Mr. Rosenberg has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Eisai. The institution of Mr. Rosenberg has received research support from Neurotrials Research.
Caroline Streicher (Axsome Therapeutics)	Caroline Streicher has received personal compensation for serving as an employee of Axsome Therapeutics. Caroline Streicher has stock in Axsome Therapeutics.
	No disclosure on file
	No disclosure on file
Herriot Tabuteau (Axsome Therapeutics)	Herriot Tabuteau has received personal compensation in the range of $100,000-$499,999 for serving as an officer or member of the Board of Directors for Axsome Therapeutics.

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