In this research study the investigators want to learn more about whether the medication Solriamfetol improves daytime sleepiness in workers who start work at very early times (between 3 and 6am).
Shift work has become increasingly common as the 24/7 global society has required more and more workers to do their jobs at irregular hours. According to the National Health Interview Survey in 2010, approximately 28.7% of the American workforce is engaged in work outside a regular day shift (outside 7 AM-to 6 PM). Working irregular hours poses a serious threat to the shift worker's physical, mental, and psychosocial health due to circadian misalignment and misplaced sleep. The most severe problems faced by shift workers are sleep disturbances and excessive sleepiness. The disruptions caused by shift work are recognized as a circadian rhythm sleep disorder in the International Classification of Sleep Disorders, 3rd Edition, and is called Shift Work Disorder \[SWD\]. SWD is characterized by excessive sleepiness (ES) during wakefulness, accompanied by a reduction of total sleep time and/or insomnia. Several studies have shown that 10-43% of shift workers are diagnosed with SWD, dependent on the criteria used. Studies have shown that wake promoting agents can be used to treat ES in shift workers, ranging from caffeine to prescription pharmacological agents. Current Food and Drug Administration (FDA)-approved options for SWD patients with ES are modafinil and armodafinil. A three-month, double-blind trial of 209 randomized SWD patients showed that modafinil improves wakefulness and the ability to sustain attention working night shifts without negatively affecting daytime sleep. Furthermore, SWD patients who received modafinil had an improvement in clinical symptoms, reduced levels of sleepiness during night shift and during commute home, and proportionally fewer patients reported motor vehicle accidents or near accidents while commuting home. Czeisler and colleagues also performed a 12-week randomized, double-blind, placebo-controlled, parallel-group, multicenter study, which showed that armodafinil was well-tolerated and improved clinical conditions, wakefulness, attention and memory during night shifts in SWD patients without jeopardizing daytime sleep and reduced sleepiness during the commute home. All these previous studies were described in SWD patients working night shifts, yet approximately 3 times as many individuals work shifts that start in the early morning compared with those who work night shifts. These early-morning shift workers are a unique, high-risk group because their early work start times (3:00 AM to 6:00 AM) require the workers to wake up in the middle of the night, close to their circadian nadir, resulting in curtailed sleep and commuting to work during times of high sleepiness. Previous research has shown that early-morning shift starts in particular are associated with increased sleepiness. To the investigators' knowledge, no studies have addressed the use of wake promoting agents for ES in early-morning shift workers. In this clinical trial, the investigators will test whether Solriamfetol (SUNOSITM), a drug approved for the treatment of ES in patients with obstructive sleep apnea (OSA) and narcolepsy, is effective in: (1) decreasing sleepiness without reducing sleep duration or sleep quality; (2) improving work functioning; and (3) improving quality of life in early-morning shift workers diagnosed with ES associated with SWD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
84
The administered drug is SUNOSI (solriamfetol) tablets for oral use. Initial U.S. Approval: 2019
Control subjects will receive placebo tablets for oral use.
Brigham and Women's Hospital
Boston, Massachusetts, United States
Change in Mean Sleep Latency
Sleep latency was assessed with a Maintenance Wakefulness Test (MWT) at Visit 2 (Baseline) and again at Visit 5 (End-of-Treatment). The MWT started \~2 hours after participant's usual wake time and consisted of four 40-minute trials (2, 4, 6, and 8 hours after usual wake time). Participants were fitted with polysomnography (PSG) and instructed to stay awake. Each trial was monitored and the trial was ended after PSG-sleep occurred or after 40 minutes if no sleep occurred. Sleep latency (in minutes) was calculated as the time between trial start time and sleep onset time. Change in mean sleep latency (i.e., averaged sleep latency across the four trials) from Visit 2 to Visit 5 was calculated for each participant.
Time frame: Study Visit 2 (i.e., Baseline Visit) and Study Visit 5 (i.e., End-of-Treatment Visit after 4 weeks on solriamfetol or placebo)
Change in Karolinska Sleepiness Scale Score
Subjective sleepiness was assessed with a Karolinska Sleepiness Scale (KSS, Åkerstedt \& Gillberg, 1990). The KSS was administered to the participant \~5 minutes before the start of each four MWT trial at Visit 5 (Baseline) and again at Visit 5 (End-of-Treatment). The KSS scores range from 1 (very alert) to 9 (very sleepy), with higher scores indicating higher levels of sleepiness. Change in the mean KSS score (i.e., averaged score across the four trials) from Visit 2 to Visit 5 was calculated for each participant.
Time frame: Study Visit 2 (i.e., Baseline Visit) and Study Visit 5 (i.e., End-of-Treatment Visit after 4 weeks on solriamfetol or placebo)
Change in Clinician's Global Impression of Change Score
Overall change in participant's clinical condition was assessed with a Clinician's Global Impression of Change scale (CGI-Change, Guy, 1976). The CGI-change was conducted at Visit 5 (End-of-Treatment) by a study doctor who rated the participant. The scores range from 1 (very much improved) to 7 (very much worse), with lower scores indicating improved condition. Data were dichotomized such that scores 1-3 (very much improved, much improved, minimally improved) were considered to indicate improvement and scores 4-7 (no change, minimally worse, much worse, very much worse) were considered to indicate no improvement. Improvement was calculate as the percentage of participants in each group who reported improved scores.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Study Visit 5 (i.e., End-of-Treatment Visit after 4 weeks on solriamfetol or placebo)
Change in Patient's Global Impression of Change Score
Participant's overall perception of change in their condition (i.e., excessive sleepiness) was assessed with a Patient's Global Impression of Change scale (PGI-Change, Guy, 1976). The PGI-C was administered to the participant at Visit 5 (End-of-Treatment). The scores ranged from 1 (no change or worse) to 7 (a great deal better), with higher scores indicating improved condition. Data were dichotomized such that scores 1-2 (no change or worse, hardly any change) were considered to indicate no improvement, and scores 3-7 (a little better, somewhat better, moderately better, better, a great deal better) were considered to indicate improvement.
Time frame: Study Visit 5 (i.e., End-of-Treatment Visit after 4 weeks on solriamfetol or placebo)