e302
`
`Abstracts / Sleep Medicine 14S (2013) e239–e317
`
`Clinical study on sleep-regulating technique (TIP3–2) combined
`with medication of treating primary
`W. Wang, L. Hong, Y. Lin, F. Wang, T. Li, W. Wang, G. Li
`Psychology and Sleep Department in Guang-anmen Hospital, China
`Academy of Chinese Medical Sciences, China
`
`Study on clinical efficacy of treating primary insomnia by wen
`dan ning xin grain
`W. Wang, Y. Liu, L. Hong, Y. Lin, F. Wang, W. Wang, G. Li
`Psychology and Sleep Department of Guangán men Hospital, China
`Academy of Chinese Medical Sciences, China
`
`Introduction: Cognitive behavioral therapy (CBT) and hypnotic
`medications are efficacious for short-term treatment of insomnia,
`but few patients achieve complete remission with any single
`treatment. In patients with persistent insomnia, the addition of
`medication to CBT produced added benefits during acute therapy.
`Sleep- regulating Technique (TIP3–2) is a Symptomatic treatment
`method of Low Resistance Thought Induction Psychotherapy (TIP).
`TIP is a psychotherapy of treating insomnia or other mental disor-
`ders accompanying with insomnia. TIP is a therapy developed based
`on low resistance theory and thought induction theory. It combines
`the eastern Guidance (Dao Yin) and Qigong with western suggestion
`and hypnotherapy.
`It is supposed that this can create a low
`resistance background. Then to treat the patients use some psycho-
`therapy in this condition. Sleep-regulating Technique (TIP3–2) has
`standard operating procedures and induction word for different
`symptoms of the patients. The objective of this study is to observe
`the curative effect of primary insomnia using Sleep-regulating
`Technique (TIP3–2) combined with medication.
`Materials and methods: 70 primary insomnia patients were ran-
`domly divided into two groups, TIP combined with medication and
`only medication, and 35 cases Each group. The patients in medication
`group were given 1¡«2 mg Estazolam half an hour before going to bed.
`On the basis of taking Estazolam, the patients in TIP combined with
`medication group were given Sleep-regulating Technique treatment
`twice a week. Observed the changes of Pittsburgh sleep quality index
`(PSQI) before and after treatment, and the period is 4 weeks.
`Results: Comparison in group: In TIP combined with medication
`group, there are improvement in total score of PSQI, subjective sleep
`quality, sleep latency, sleep duration, habitual sleep efficiency, sleep
`disturbances, use of sleeping medication, daytime dysfunction in
`statistical significance (P<0.05). In medication group, the total score
`of PSQI, Subjective sleep quality, sleep duration have statistical
`significance improvement (P<0.05); Comparison between groups:
`Comparing the data after treatment, There were significant differ-
`ences in the total score of PSQI, subjective sleep quality, medication
`use and daytime dysfunction ( P<0.05 ). TIP combined with medica-
`tion is better than only medication. Comparing the difference of PSQI
`values before and after treatment, there are significant difference
`between two groups in the total score of PSQI, subjective sleep qual-
`ity, sleep latency, medication use and daytime dysfunction (P<0.05 ).
`TIP combined with medication is better than only medication.
`Conclusion: The two methods have different degrees of improve-
`ment in primary insomnia. TIP combined with medication is better
`than only medication. It is suggested that psychological therapy com-
`bined with medication therapy is a more effective treatment of
`insomnia.
`Acknowledgements: Research was funded by the following project:
`Prevention and treatment study of Chinese Traditional Medicine on
`psychological diseases:Project supported by the National Key Tech-
`nology Research and Development Program of the Ministry of Sci-
`ence and Technology of China (Grant No. 2009BAI77B09). And
`thanks to all the members cooperation and the participants who
`help us accomplish the study.
`
`http://dx.doi.org/10.1016/j.sleep.2013.11.739
`
`Introduction: Wen Dan Ning Xin grain is a preparation which can
`only be prescribed in Guangán men Hospital in China. Its basic
`components comes from an ancient Chinese medical book called
`Zheng Zhi Zhun Sheng. It is developed by a Chinese famous doctor
`Rong-lin Gao, and has been used in clinical for about 10 years. It is
`said that this is an effective method of treating insomnia. This study
`is to observe the clinical efficacy of treating primary insomnia.
`Materials and methods: 70 primary insomnia patients were ran-
`domly divided into two groups, Wen Dan Ning Xin Grain group
`and Estazolam group, and 35 cases each group. Patients in Wen
`Dan Ning Xin Grain group were given Wen Dan Ning Xin Grain,
`6 g every time and 3 times a day.The patients in Estazolam group
`were given 1 < 2 mg Estazolam half an hour before going to bed.
`Observed the changes of Pittsburgh sleep quality index (PSQI) before
`and after treatment, and the observation period is 4 weeks.
`Results: Wen Dan Ning Xin grain increased sleep duration,
`improved subjective sleep quality, reduced sleep disturbances and
`generally improved insomnia (P < 0.05); Estazolam only improved
`subjective sleep quality (P < 0.05). Comparison between groups, in
`terms of daytime dysfunction and total scores of PSQI, Wen Dan Ning
`Xin grain is better than Estazolam (P < 0.05). Additionally, effective
`rate of Wen Dan Ning Xin grain is higher than Estazolam.
`Conclusion: Although there is selection bias in this study, it is
`inevitable in Traditional Chinese Medicine hospital in China. The
`data in this paper is suggested that Wen Dan Ning Xin grain is better
`than Estazolam for primary insomnia in Traditional Chinese
`medicine hospital, and further study is needed.
`Acknowledgements: Research was funded by the following project:
`Prevention and treatment study of Chinese Traditional Medicine on
`psychological diseases:Project supported by the National Key
`Technology Research and Development Program of the Ministry of
`Science and Technology of China (Grant No. 2009BAI77B09). And
`thanks to all the members cooperation and the participants who
`help us accomplish the study.
`
`http://dx.doi.org/10.1016/j.sleep.2013.11.740
`
`Evaluation of drug–drug interactions of sodium oxybate with
`divalproex: Results from a pharmacokinetic/pharmacodynamic
`study
`M. Eller 1, Y. Wang 1, K. Wesnes 2, S. Alvarez-Horine 1, B. Benson 1,
`J. Black 1
`1 Jazz Pharmaceuticals, Inc., United States
`2 Bracket, United States
`
`sodium
`Introduction: To evaluate drug-drug interactions of
`oxybate (SXB) and divalproex sodium ER (DVP) with regard to PK,
`PD, and safety. SXB is the sodium salt of gamma-hydroxybutyrate
`(GHB), a substrate for monocarboxylate transporter and GHB
`dehydrogenase; both are inhibited by valproic acid.
`Materials and methods: Healthy volunteers were randomized to
`one of 4 treatment sequences in a 5-period, double-blind, crossover
`design with washout between periods. During Periods 1 and 2,
`subjects received two 3g doses of SXB or placebo 4h apart in a cross-
`over fashion (days 1 and 3). In Period 3 (days 5–14), subjects
`
`PAR1028
`IPR of U.S. Patent No. 8,772,306
`Page 1 of 2
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`

`
`Abstracts / Sleep Medicine 14S (2013) e239–e317
`
`e303
`
`received DVP 1250 mg, and continued DVP during Periods 4 and 5
`(days 15–18), with two 3 g doses of SXB or placebo administered
`4h apart in a crossover fashion on Days 15 and 18. Blood and urine
`samples were taken at predefined times for PK analysis. PD testing,
`performed during SXB treatment, included the Karolinska Sleepiness
`Scale, and several automated tests
`from CDR System (www.
`bracketglobal.com) including Simple Reaction Time, Digit Vigilance,
`Choice Reaction Time, Tracking, and Numeric Working Memory
`tasks. Safety was assessed throughout the study.
`Results: 20 subjects enrolled and completed the study (all male,
`65% white, mean age 33.9 ± 6.6 y). Geometric LS means of SXB
`with SXB + DVP relative to SXB alone were significantly higher
`for plasma AUC0-inf (349.7 vs. 275.6 lg * h/mL; P < 0.0001) and
`renal clearance (606.0 vs. 480.5 mL/h; P < 0.001), and upper
`bounds of the 90% CIs of the percent mean ratios exceeded the
`equivalence range of 80–125%. No changes in DVP PK were
`observed with SXB+DVP. SXB induced sleepiness and cognitive
`impairments. SXB + DVP produced significantly greater deficits
`(P < 0.05) at several time points than SXB alone in numeric work-
`ing memory mean reaction time, simple reaction time mean, digit
`vigilance accuracy, choice reaction time accuracy, continuity of
`attention, and tracking distance from target. The most common
`adverse events (AEs) were consistent with the drug profiles. AEs
`in P2 subjects with SXB + DVP were somnolence, n = 18; euphoric
`mood, n=10; dizziness, n = 7; and nausea, n = 4.
`Conclusion: SXB + DVP showed changes in SXB PK and renal
`clearance consistent with GHB dehydrogenase and monocarboxy-
`late transporter inhibition. SXB produced sleepiness and cognitive
`impairments; some cognitive domains showed greater impairment
`with DVP co-administration, consistent with SXB PK changes. AEs
`with SXB + DVP reflect a combined drug effect.
`Acknowledgement: This study was sponsored by Jazz Pharmaceuti-
`cals, Inc.
`
`http://dx.doi.org/10.1016/j.sleep.2013.11.741
`
`What is known about the experience of CPAP for OSA from the
`users’ perspective? A systematic integrative literature review
`K. Ward 1,2, M. Gott 1,2
`1 The University of Auckland, Faculty of Medical & Health Sciences:
`School of Nursing, New Zealand
`2 The University of Auckland, Faculty of Medical & Health Sciences:
`School of Nursing & School pf Popu, New Zealand
`
`Introduction: The estimated economic, social and personal cost
`of untreated obstructive sleep apnoea (OSA) is high. Night time
`continuous positive airway pressure (CPAP) is a recommended,
`cost effective and popular treatment. The predicted global increase
`in obesity will
`lead to increasing prevalence of OSA. Exploring
`management of CPAP from the user perspective is crucial to suc-
`cessful administration of this therapy. The objective was synthesis
`of the international evidence base regarding users’ experience of
`night
`time continuous positive airway pressure therapy for
`obstructive sleep apnoea.
`Materials and methods: A systematic integrative literature review
`was conducted and quality assessment criteria applied.
`Results: From 538 identified papers, 22 met inclusion criteria.
`Thematic analysis identified four themes: (1) evidence regarding
`experience of CPAP and issues of research design; (2) CPAP influ-
`enced by users’ views and beliefs; (3) CPAP investigated using a
`language of difficulty; and (4) spouse and family impact on CPAP
`use. Overall, research relating to user experience of CPAP is
`limited. Understanding is incomplete because of problems of study
`
`design, for example the use of pre-determined checklists and sur-
`vey questions. The problem oriented terminology adopted by most
`studies is also likely to set up the expectation that users will
`encounter difficulties with CPAP. There is evidence that personal-
`ity and attitude impact expectations about CPAP prior to and dur-
`ing use, whilst engagement of spouse, family and colleagues also
`influence experience.
`Conclusion: This comprehensive integrative review identified lim-
`ited evidence about experiencing CPAP from the users’ perspective.
`Current research is constrained by researchers’ concern with non-
`compliance. Typically experiences of CPAP are not defined by the
`user, but from an ‘expert’ healthcare perspective, using language that
`defines CPAP as problematic. Family and social support is a signifi-
`cant, but underexplored, element of experiencing CPAP and warrants
`further investigation. Research that more comprehensively involves
`CPAP users is required to determine how patients manage this ther-
`apy successfully.
`Acknowledgement: Acknowledgements go to both supervisors
`Merryn Gott and Karen Hoare.
`
`http://dx.doi.org/10.1016/j.sleep.2013.11.742
`
`Repetitive transcranial magnetic stimulation enhances sleep
`quality of patients with comorbid major depressive disorder and
`insomnia
`T. Li, W. Wang, L. Hong, Y. Lin, F. Wang
`Sleep Medicine Committee of World Federation of Chinese Medicine
`Societies, Department of Sleep and Psychology, Guanganmen Hospital,
`China Academy of Chinese Medical Sciences, Beijing, PR China
`
`Introduction: Insomnia impacts the course of major depressive
`disorder (MDD), obstructs response to treatment, and raises risk of
`depression relapse. This study approached how repetitive transcra-
`nial magnetic stimulation (rTMS) relieves depression and enhances
`sleep quality of patients with comorbid major depressive disorder
`and insomnia.
`Materials and methods: A randomized, controlled, pilot study was
`conducted in our hospital. The study was approved by local Ethics
`Committee. All subjects signed informed consents. 30 patients, con-
`forming to meet the Diagnostic and Statistical Manual of Mental Dis-
`orders (DSM–IV–TR) criteria for MDD, and Montgomery–Asberg
`Depression Scale (MADRS) score between 12 and 29 were randomly
`chosen as the MDD group. Another 30 patients, meeting the DSM–
`IV–TR criteria for MDD and insomnia, MADRS score between 12
`and 29, and Pitts-burgh Sleep Quality Index (PSQI) scores >7, were
`randomly selected as the MDD and insomnia group. Both groups
`received rTMS (10 Hz for 4 weeks) once per day. After treatment,
`patients’ depression was assessed with MADRS, and their sleep qual-
`ity was evaluated by PSQI. Raters were masked to treatment
`assignment.
`Results: There were 30 subjects in MDD group (60% female, mean
`age 38.56 ± 12.13 s.d. mean course of disease 11.35 ± 7.53 months).
`MDD and insomnia group consisted of 30 subjects (66.67% female,
`mean age 32.72 ± 14.69 s.d. mean course of disease 9.23 ± 4.81
`months). Although the rate of depression remission in MDD and
`insomnia group (59.36%) was higher than MDD group (57.21%), this
`difference was not significant. After 4 weeks treatment, both MDD
`group (12.56 ± 6.73) and MDD insomnia group (11.38 ± 7.16 s.d.)
`were significantly improved in MADRS scores (P<0.05). MDD and
`insomnia group was significantly improved (P<0.05) in PSQI sleep
`quality (1.40 ± 0.41), time for falling asleep (1.73 ± 1.21), sleep time
`(1.90 ± 1.28), sleep efficiency (0.90 ± 1.52), Function during the day-
`time (1.87 ± 0.84), total score (8.57 ± 3.74).
`
`PAR1028
`IPR of U.S. Patent No. 8,772,306
`Page 2 of 2