Neurofeedback for Insomnia: Pilot Study of Z-Score Sensorimotor & Individualized Protocols
This pilot study investigates the effectiveness of Z-Score Sensorimotor and Individualized Neurofeedback protocols for insomnia. Primary insomnia is defined, highlighting its impact and limitations of pharmacotherapy. Psychological treatments and challenges in service delivery are discussed, emphasizing the potential of Neurofeedback as a promising intervention. The study addresses the prevalence of insomnia, its association with co-morbidities, and the need for innovative treatment approaches.
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A New Look at an Old Workhorse: A Pilot Study of Z-Score Sensorimotor & Individualized Neurofeedback See full text at: Hammer, B.U., Colbert, A.P., Brown, K.A. and Ilioi, E. C. (2011). Neurofeedback for Insomnia: A Pilot Study of Z-Score SMR and Individualized Protocols. Appl. Psychophysiol Biofeedback, DOI 10.1007/s10484-011-9165-y Email: barbhammer37@yahoo.com
Barbara U. Hammer, Ph.D., Agatha P. Colbert, MD, Kimberly A. Brown, MSOM, Helfgott Research Institute, National College of Natural Medicine, Portland, OR, Elena C. Ilioi, Psychology Honours, McGill University, Montreal, Quebec, Canada The authors are grateful to the Helfgott Research Institute of the National College of Natural Medicine in Portland, Oregon for its generous support of this research. We are especially appreciative of the help from Mark L. Smith and Nancy Wigton on the design of the protocols, William Gregory and Heather Jaskirat Wild for her assistance with the data analysis, and the generous support of our research assistants, Sean E. Griffith and Tineke Malus. We thank all those who participated in this study, including those who took the time to complete the telephone screening and the extended screening sessions but who were not offered the opportunity to continue and to receive treatment.
Insomnia Definition Primary Insomnia (DSM 307.44): Complaints of Difficulty Falling Asleep, Staying Asleep or Awakening too early, or Non-restorative Sleep which occurs for at least one month and: 1. Causes significant distress or impairment in social, occupational, or other important areas of functioning. 2. Does not occur exclusively during the course of Narcolepsy, Breathing-Related Disorder, Circadian Rhythm Sleep Disorder or a Parasomnia. 3. Does not occur exclusively during the course of another mental disorder. 4. Is not due to the direct physiological effects of a substance or general medical condition.
2005 NIH Conference on Insomnia declared Insomnia an Epidemic: 20-30% of adults in the U.S. suffer from Insomnia\ Insomnia associated with increased Illness, accidents, healthcare utilization, and industrial expenses Costs estimated at $14-80 billion annually Pharmacotherapy limited due to negative side effects
Psychological treatments highest co-morbidity Insomnia persists despite psychotherapy for depression or anxiety Cognitive Behavior Therapy demonstrated 70% efficacy , effectiveness, efficiency for treatment of Insomnia but seldom used difficult to administer requiring specialized training/many sessions Challenges remain primarily in service delivery system. Internet based program promising Neurofeedback SMR from Sterman 1960 s to Hauri (1980 s)=cats to humans, improved sleep Theta benefitted tense insomniacs Individualized studied here
Peter Hauri (9/2008): SMR Neurofeedback in 1980 s used Analog Equipment not feasible for general clinical use: Too Expensive Too Cumbersome Too Time consuming Time to revisit SMR for Insomnia with Digital equipment and new training methods.
Pilot Study Overview: IRB approved 8/2008 Purpose Compare treatment effects of Z score NFB SMR & sequential, quantitative EEG (sQEEG) guided Individually Designed (IND) protocols for Rx of Insomnia. Methods Eight completed single-blind study. Intervention Fifteen 20-minute sessions Z-Score NFB. Pre-treatment Screening Medical History Questionnaire Psychiatric Diagnostic Screening Inventory (PDSQ) plus: Pre-post measures Insomnia Severity Index (ISI) Pittsburgh Sleep Quality Index (PSQI) Psychopathology (MMPI-2-RF) Clinical Interview Satisfaction/Happiness Quality of Life Index (QOLI) sQEEG
PARTICIPANTS: 25+ Telephone Screening unpaid, recruited over 4 months Exclusions use of sleep aids, psychotropic meds, meds that impact sleep, mental disorders, physical disorders that could interfere, prior NFB, enrolled in another sleep study, pregnant or shift worker 12 Selected/Met DSM 307.44 criteria 2 Declined to start due to personal/extraneous reasons 2 Dropped out due to personal/external reasons >8 visits
Excluded Not meeting inclusion criteria (n=10) Assessed for eligibility Assessed for eligibility (n=25) (n=3) Enrolled & Randomized (n=12) Declined to continue (n-2) Treated (n=10) SMR Allocated to intervention (n=6) Did not receive allocated intervention (n=1) Give reasons Declined midway due to scheduling conflicts IND Allocated to intervention (n=4) Did not receive allocated intervention (n=1) Give reasons Declined midway due to scheduling conflicts Lost to follow-up (n=1) Lost to follow-up (n=1) Diqualified (n=1) Diqualified (n=1) Discontinued (n=0) Discontinued (n=0) Analyzed (n=3) Analyzed (n=5) Figure 1. STUDY FLOW CHART
Sleep Measures ISI= Insomnia Severity Index--Perceived Severity of Symptoms + Daytime Dysfunctions for past 1-2weeks PSQI=Pittsburgh Sleep Quality Inventory--General Sleep Disturbance + Daytime Dysfunctions for past 1month Daily Sleep Diaries=from Screening Visits to Post Testing-- recordings of bedtime, rising time, estimated latency, WASO, TST, Sleep Quality 1-10, adverse events or unusual circumstances Actiwatch=72hours pre and post treatment
Measures of Daytime Functioning MMPI-2 RF-Most widely researched, used measure of psychopathology. Newest version Psychiatric Diagnostic Screening-Questionnaire- PDSQ Guide to depth clinical interview to confirm absent Dx Quality of Life Index-QOLI Measures positive mental health=daytime function
Objective Physiological Measures sQEEG=Quantitative Electroencephalogram Profiles the brain s electrical functioning in direct comparison with normative database (NeuroGuide). Like other direct physiological measures, such as blood sugar, lipids or liver enzymes, the EEG has demonstrated high reliability Actiwatch-Numerous technical difficulties invalidated use
sQEEGEEG General Screening Records several minutes at 4 scalp sites in 5 runs for total of 19 of 10/20 sites Records overall synchrony measures between each set of 4 sites BrainMaster Certified Calibration tested EEG amplifier for NFB/QEEG
NFB=Operant Conditioning to Norm Training to Norm =Normalizing physiological process via self-regulating brainwave distribution Based on Principles of Learning via Operant Conditioning Z-Score NFB designed to use Live, Instantaneous record as basis of Reinforcement
Experimental Groups Group 1 Z-Score Individualized Protocol (IND) = Normalized 4 highest abnormal site(s) (HAS4) via reward of correct enhancement or inhibition of variables > 1.96 Z , at increasingly larger percentage of normal Z scores. Modified PZOKUL. Group 2 Z-Score SMR Protocol (SMR) = Training at Cz and C4, LE, reward production of SMR (12-15Hz) & inhibition of excessive theta & high beta, & all other amplitudes & connectivity measures within normal. Modified PZOKUL . General Training Procedure = Initial % of all variables in the normal range =50% raised as % Time >80 Z scores normal. When % variables >80, Z score limit was reduced as far as possible.
Table 1. Demographics, Complaints, Global Sleep Scores Subject Number 1 Age Sex Duration Symptoms Group Pre ISI 18 Pre PSQI 14 61 F Since Childhood 1-5 Years WASO,WE SMR 2 50 F WASO SMR 15 11 3 34 M 5 Years SOL,WASO SMR 19 17 4 40 M 1 Year SOL,WASO SMR 17 16 5 54 F 20+ Years WE,WASO, SOL WE,SOL IND 14 9 6 50 F 22+ Years IND 12 11 7 58 F Since Childhood 10+ Years SOL,WASO ,WE NS,WASO, WE SMR 28 17 8 50 M IND 14 12 Mean 49.63 17.13 13.38 Note: WASO=Wake after sleep onset WE=Wake too early SOL=Sleep onset latency NS=Non-restorative sleep, SMR=Z-Score SMR Neurofeedback IND=sQEEG guided individualized Z-Score protocol. These Pre-treatment ISI and PSQI scores are comparable to those of insomnia patients in other insomnia studies with larger patient samples (Sleep, 2005). ISI score range=0-28, PSQI score range =0-21, cutoff >5.
Success of Training All subjects reached training goal of 80% correct within normal range for 80% of the training time. Four of 5 in SMR improved SMR Z-scores (toward 0) at training sites ANOVA Age, sex, PDSQ, Group not significant covariates. Groups combined for all measures. Pre-Post Significant Changes Significant improvement on all primary sleep measures. See Table 2 & 3, Figs 2 & 3 Sleep Efficiency above diagnostic cutoff Post treatment WASO significantly improved in half. QOLI significantly improved MMPI clinical improvement sQEEG significant lowering of Delta (sleepiness) & Beta (arousal) Table 4 Six month Follow-up Six of 8 responded Five of 6 remained free of insomnia, one returned to baseline, 3 improved from baseline
Table 2. Primary Sleep and Quality of Life Measures p Measure PRE MEAN- (95% CI) POST MEAN- (95% CI) F 17.13 [15.794,18.466] 6.56 - [5.901, 7.220] <.005 ISI 18.2 13.38 [12.506, 14.254] 4.50 - [4.194, 4.806] PSQI-T 55.6 <.0001 PSQI-SE 15.8 <.007 [74.85, 80.43] [91.87,94.49] 46.13 [42.908, 49.352] 52.63 [49.827, 55.433] <.02 QOLI 9.6 Notes: ISI=Insomnia severity index PSQI-T=Pittsburgh sleep quality index - total PSQI-SE= Pittsburgh sleep quality index total - sleep efficiency QOLI=Quality of life index. All measures are based on the eight completers. Lower ISI and PSQI total scores are better. Higher QOLI and PSQI-SE scores are better. Significant post-treatment improvement on all measures.
Table 3. Post Treatment Change Summary #/Group #Rx WASO 1-SMR 15 Final %ZOK Increase SE% Increase TST -1 0 80 7.2 75 2-SMR 9 95 14.3 60 -2 3-SMR 13 86 27.1 90 -3 4-SMR 15 5-IND 15 90 85 23 8.7 60 0 0 0 6-IND 15 93 7 30 0 7-SMR 15 87 28.6 120 -2 8-IND 15 88 11.1 60 Mean 88% +15.88% +61.88 Min.
Table 4. Binomial tests of sQEEG Changes Pre to Post Treatment
Pittsburgh Sleep Quality Index (PSQI) PSQI Pre PSQI Post 18 PSQI Total Score 16 14 12 10 8 6 4 2 0 1/SMR 2/SMR 3/SMR 4/SMR 5/IND 6/IND 7/SMR 8/IND SMR-1 SMR-2 SMR-3 SMR-4 Participant Subject Number/Group IND-1 IND-2 SMR-5 IND-3 Figure 2: PSQI Pre-Post Change in Global Sleep Scores
Actiwatch72 Hour data pre-post with Multiple Technical Difficulties Prevented Analysis Click sound inaudible Possibly defective recording hardware Possibly defective recording software Vender suggested corrections via Sleep Log questionable User errors discovered too late to re-train
Adverse Events None reported __________________________ Two drop-outs induced) interfering with treatment schedule Unexpected life-style changes (trauma
Conclusions: 1. Baseline EEGs showed both excessive sleepiness and hyperarousal, which significantly improved post- treatment. 2. Both NFB protocols provided significant improvement in self reported sleep, daytime functioning, mental health, and sQEEG. 3. SMR treatment at least as effective as IND, and significantly less burdensome to administer.
Discussion 1) Data replicates early SMR studies with new equipment and advanced software/training designs 2) Z score NFB possibly effective at 8 Rx sessions (160 ) training time, possibly faster than traditional NFB & CBT 3) SMR at least as effective as Individually designed protocol based on sQEEG 4) Participants improved on ALL self-report sleep measures, quality of life, and mental health
Discussion (continued) 5) All Participants became normal sleepers, relatively quickly 6) Safe, well-tolerated, non-pharmacological, Non-Invasive 7) SMR easily practiced clinically
Limitations: 1) Small Sample Size 2) Regression toward Mean 3) Lack of Control group 4) Single Blind Design 5) Lack of useful Actiwatch/objective sleep measure 6) Lack of EEG connectivity measures in IND
I love sleep. My life has the tendency to fall apart when I'm awake, you know? Ernest Hemingway
