Comparison of actigraphy and polysomnography to assess effects of zolpidem in a clinical research unit.
OBJECTIVE
This study sought to compare devices that use actigraphy for measuring sleep endpoints in the clinical research unit (CRU) and home environment. The abilities of polysomnography (PSG) and actigraphy monitors to detect drug effects in a CRU were also investigated.


METHODS
Eleven healthy subjects were recruited and monitored with PSG for four consecutive nights in a CRU after receiving no treatment (night 1, N1), and then placebo or 5 mg day(-1) or 10 mg day(-1) zolpidem in a randomised, cross-over design. Subjects wore two devices that use actigraphy (a Respironics® Actiwatch® on the wrist and a BodyMedia® Sensewear® Armband on the upper-arm) on the non-dominant arm for five nights at home and four nights in the CRU during PSG.


RESULTS
Wake after sleep onset (WASO) and total sleep time (TST) measured by PSG and estimates of WASO by the Actiwatch decreased significantly with 5mg but not 10mg of zolpidem versus placebo. Direct activity (counts/min) with the Actiwatch decreased in response to zolpidem (both 5 and 10 mg day(-1)) versus placebo. Armband recordings of direct activity were similar to the Actiwatch but not significantly different versus placebo. Both actigraphy device estimates of TST were approximately 1h longer in CRU versus home. Agreement between actigraphy estimates of TST and WASO and PSG values of TST and WASO were closer during nights with zolpidem treatment.


CONCLUSIONS
PSG can detect the effects of zolpidem on sleep in a CRU setting. Actigraphy can provide useful assessment of sleep, but direct activity endpoints may be more effective than estimates of TST and WASO.
Pfizer Global Research & Development, Groton/New London Laboratories, Pfizer Inc, Groton, CT 06340, USA. barry.t.peterson@gmail.com
Barry T
BT
Peterson
Ping
P
Chiao
Eve
E
Pickering
Jon
J
Freeman
Gary K
GK
Zammit
Yu
Y
Ding
Lori L
LL
Badura
D056044:Actigraphy / Q000379:methods* / Q000592:standards; D000328:Adult; D018592:Cross-Over Studies; D016903:Drug Monitoring / Q000379:methods* / Q000592:standards; D004777:Environment; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009622:Noise; D017286:Polysomnography / Q000379:methods* / Q000592:standards; D011725:Pyridines / Q000008:administration & dosage*; D012016:Reference Values; D012890:Sleep / Q000187:drug effects*; D055815:Young Adult; D000077334:Zolpidem
D006993:Hypnotics and Sedatives; D011725:Pyridines; D000077334:Zolpidem