SLEEP 2011 Abstract Supplement

B. Clinical Sleep Science VIII. Medical Disorders and Sleep
space neuromas confirmed by ultrasound were each injected with 1 ml
lidocaine/bupivacaine/methylprednisolone/dexamethasone/ 4% alcohol.
Results: Within 48 hours of injection, sleep logs/VAS in 5 of 6 cases
showed improving sleep quality and fatigue levels. QUESTIONNAIRE
baseline (B) score: C1-6 mean (range), % Improvement (% I) at 7-14
days post-injections: C1-6 mean/(range): IRLS (C1-5 only) B: 31(25-
39), % I: 68% (21-96); PSQI B: 12(8-17), % I: 51% (0-88); FSS B:
48(39-56), % I: 53% (6-78); MAF B: 36(28-43), % I: 57% (13-78); FFS
B: 22(13-30), % I: 61% (22-100). Treatment benefit continued over 1-4
months’ follow-up.
Conclusion: PIF in 5 of 6 cases was sleep-related and largely reversible
by neuroma injections. Despite 2 distinct triggering infections, the PIF/
LR symptom complex and its prompt progressive improvement were
similar. We recommend further study of PIF as reversible sleep dysfunction.
0690
BEDTIME VERY LOW DOSE (VLD) CYCLOBENZAPRINE
INCREASES NIGHTS WITH NORMALIZED CYCLIC
ALTERNATING PATTERN (CAP) A2+A3 RATE ≤ 33% IN
FIBROMYALGIA SYNDROME (FMS) WHICH CORRELATES
WITH IMPROVEMENTS IN FATIGUE AND MOOD
Moldofsky H 2 , Harris HW 1 , Archambault T 3 , Kwong T 2 , Lederman S 1
1
TONIX Pharmaceuticals, New York, NY, USA, 2 Sleep Disorders
Clinics, Centre for Sleep & Chronobiology, University of Toronto,
Toronto, ON, Canada, 3 VirtuStat, North Wales, PA, USA
Introduction: Fibromyalgia Syndrome (FMS) is characterized by
chronic pain, tenderness, unrefreshing sleep, fatigue and depressed
mood. Disordered sleep in FMS has increases in the periodic nonREM
sleep known as the Cyclic Alternating Pattern (CAP) (Rizzi, Sarzi-Puttini
et al. 2004, Moldofsky et al 2010). Subtypes CAP A2 and A3 are
indices of sleep instability while subtype CAP A1 is a measure of sleep
stability. Previously, we showed that very low dose (VLD) cyclobenzaprine
(CBP) improved core symptoms of FMS (Moldofsky H 2002). In
a retrospective analysis, we tested whether VLD CBP decreases CAP
A2+A3 and whether such changes potentially correlate with improvements
in FMS symptoms.
Methods: Our double blind placebo-controlled study (n=36) of VLD
CBP (mean dose = 3.1 mg) in FMS for 8 weeks (average 54 days) included
self-reported measures of pain, fatigue, tenderness (dolorimetry)
and mood (Hospital Anxiety and Depression [HAD] scale). Polysomnography
was performed at screen, baseline and weeks 2, 4 & 8. EEG
sleep CAP was measured by Embla automated CAP analysis system.
CAP sleep response was calculated by CAP (A2+A3 rate)/(A1+A2+A3
rate) ≤ 33% (normalized CAP A2+A3) which we found to separate treatment
effects by analyzing a range of normalized CAP A2+A3 values
from 10% to 50%. Effects of treatment were analyzed by Last Observation
Carried Forward (LOCF).
Results: VLD CBP treatment improved bedtime musculoskeletal pain
(p=0.010), tenderness (p=0.006), bedtime fatigue (p=0.039), HAD
(p=0.017), HAD depression subscale (p=0.017), and change in selfrated
(p=0.001) and clinician-rated fatigue (p=0.004). Placebo subjects
showed no improvement in these measures. VLD CBP also increased
nights with normalized CAP A2+A3 rate ≤ 33% (p=0.020) while placebo
did not. For those receiving VLD CBP, the increase in nights with
normalized CAP A2+A3 rate ≤ 33% was correlated to bedtime fatigue
(p=0.006), total HAD (p=0.033), HAD depression (p=0.017), and
self-rated (p=0.007) and clinician-rated change in fatigue (p=0.011).
Improvements in pain and tenderness did not appear significantly correlated
with nights with normalized CAP A2+A3 ≤ 33%.
Conclusion: 1. Bedtime VLD CBP treatment is associated with increased
nights with normalized CAP A2+A3 rate ≤33% which is correlated
with improvements in fatigue and mood. 2. The normalized CAP
A2+A3 rate may provide a novel biomarker for assessing treatment
effects on nonrestorative sleep and associated subjective somatic and
mood symptoms in FMS.
Support (If Any): Supported by TONIX Pharmaceuticals
0691
OBSTRUCTIVE SLEEP APNEA, SLEEP DURATION, AND
DIABETES SELF-MANAGEMENT AMONG PATIENTS WITH
POORLY CONTROLLED DIABETES
Baron KG 1,2 , Gunn HE 1 , Pandit A 2 , Curtis L 2 , Wolf MS 2
1
Neurology, Northwestern University, Chicago, IL, USA, 2 Institute for
Healthcare Studies, Northwestern University, Chicago, IL, USA
Introduction: Obstructive sleep apnea (OSA) and short sleep duration
have been associated with poorer metabolic control. The goal of this
study was to evaluate associations between OSA risk, sleep duration and
diabetes self-management.
Methods: Data were from a behavioral intervention for poorly controlled
diabetics at federally qualified health centers. The sample included
559 patients (66% women, age M(SD)=54.5 (11.0) years. Time since
diagnosis was M(SD)=1.06 (0.38) years. The majority, (79%) reported
oral medications and 44% used insulin. OSA risk was determined by
the Berlin Questionnaire and short sleep duration was determined as habitual
sleep time