Researcher Creates Zzoma For Sleep Apnea Treatment

Positional sleep apnea sufferers may soon find Zzoma, an alternative to CPAP machines, currently considered the most effective treatment for patients who stop breathing during sleep. Though CPAP (a machine that blows pressurized air through a mask to open the airway) is effective, approximately 50% of those suffering from positional sleep apnea use the machines incorrectly. Many patients find them burdensome and uncomfortable, causing non-compliance.

Six percent of our population probably has positional sleep apnea, manifested by snoring at night, and excessive daytime fatigue. Zzoma could provide the answers to this treatment according to new research.

A new device, “Zzoma”, is under study, created by former Temple Fellow Joseph G. Crocetti. Research is being conducted by Samuel Krachman, D.O., professor of medicine and director of the Sleep Disorders Center at Temple University School of Medicine and Hospital. The device is worn around the chest like a belt. A firm, foam material supports the back, preventing patients from moving onto their back – the body position that causes snoring and cessation of breathing.

Sleep apnea is a serious problem, leading to heart disease and high blood pressure. It can interfere with job performance, and lead to a host of other health problems if left untreated. Sleep apnea is an often missed diagnosis.

Dr. Krachman is hopeful the FDA will approve the sleep apnea aid, which he has been using on patients with mild to moderate sleep apnea, for study purposes, over the past year.

The source for this news is the story titled Research underway to give sleep apnea sufferers relief and rest. For more information on Sleep Apnea and treatment you can visit the site of American Sleep Apnea Association.

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Intra-Cellular Initiates Clinical Trial For Sleep Maintenance Insomnia

Intra-Cellular Therapies has initiated a sleep maintenance insomnia (SMI) Phase 2 clinical study using its drug candidate ITI-722. ITI-722 acts predominantly as a selective 5-HT2A receptor antagonist and represents an important new approach to the treatment of SMI. Because of its novel separation of 5-HT2A and dopamine receptor modulatory activities, ITI believes, ITI-722 can be used not only to treat SMI but it may be highly appropriate for the treatment of sleep disorders that accompany neurodegenerative disorders, including Parkinson’s disease and other psychiatric disorders.

%26quot;The progression of ITI-722 into Phase 2 for SMI represents the advancement of this important new class of therapeutics,%26quot; stated Sharon Mates, Ph.D., Chairman and Chief Executive Officer of Intra-Cellular Therapies. %26quot;This drug candidate has therapeutic potential to treat SMI in the general population, and in other patient populations who have been underserved, particularly peri- and post-menopausal women, and in other disorders where insomnia is a problem, including osteoarthritis, depression, Parkinson’s disease and other neurologic and psychiatric disorders.%26quot;

The Phase 2 program is a multi-center, randomized, double-blind placebo- controlled study in patients with SMI. The primary endpoint is an assessment of objective slow wave sleep using polysomnography (PSG). Secondary endpoints include other objective and subjective measures of SMI and sleep efficiency. Additionally, the study will make an assessment regarding next-day cognitive performance.

ITI-722 is a low-dose formulation of ITI-007, ITI’s first-in-class 5-HT2A antagonist/ dopamine receptor protein phosphorylation modulator (DPPM), presently in clinical trials for the treatment of schizophrenia.

About Sleep Maintenance Disorders

From nightmares to insomnia to sleep apnea, sleep disorders disrupt the sleep of millions of people all over the world. In particular, about 20% to 30% of the U.S. population complains of waking too early several times a week, a symptom of sleep maintenance insomnia (SMI) that is characterized by symptoms that include waking up frequently during the night with difficulty returning to sleep, waking up at early hours, and unrefreshing sleep. The majority of sleep complaints are related to SMI rather than sleep initiation or difficulty in falling asleep. However, there are no drugs currently approved in the U.S. that address only SMI. Furthermore, current sleep medications typically induce sedation and result in significant increases in daytime sleepiness that impairs quality of life in these patients. There is, therefore, a significant need for sleep medications that improve sleep quality without next-day hangover effects.


ITI-722 is a highly potent 5HT2A antagonist for the treatment of sleep maintenance insomnia. Preclinical data has shown that ITI-722 is not sedating and should not exhibit next-day hangover effects that are commonly associated with other sleep medications. ITI-722 is expected to have a strong safety profile with no addiction liability. This compound is being evaluated for the treatment of sleep disorders in various patient populations with sleep maintenance problems and in other sleep disorders where staying asleep affects the quality of life, including nocturnal awakenings related to osteoarthritic pain, hot flashes in post-menopausal women and many psychiatric and neurodegenerative diseases.

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Brain imaging links chronic insomnia to reversible cognitive deficits without changes in behavior

A neuroimaging study in the Sept. 1 issue of the journal Sleep is the first to find that cognitive processes related to verbal fluency are compromised in people with insomnia despite the absence of a behavioral deficit. These specific brain function alterations can be reversed, however, through non-pharmacological treatment with sleep therapy. Results of functional magnetic resonance imaging (fMRI) scanning during verbal fluency tasks show that people with insomnia have less activation than controls in the left medial prefrontal cortex and the left interior frontal gyrus, two fluency-specific brain regions. However, participants with insomnia generated more words than controls on both the category fluency task (46.4 words compared with 38.7 words) and the letter fluency task (40.1 words compared with 32.7 words).

“It was surprising to see that the patients performed at a higher level than the control group, but showed reduced brain activation in their fMRI results,” said principal investigator Ysbrand Der Werf, PhD, of the Netherlands Institute for Neuroscience in Amsterdam. “The success during the task may reflect a conscious effort to counteract the effect of poor sleep.”

Results from post-treatment neuroimaging shows that cognitive abnormalities recovered for insomnia patients who received sleep therapy, but not for those assigned to a wait-list group. Participants in the sleep therapy group also generated more words on the verbal fluency tasks after treatment than members of the wait-list group, although the results did not achieve statistical significance.

According to the authors, these results should encourage the use of sleep therapy in clinical practice as a low-cost, non-pharmacological intervention for insomnia.

The study included 21 chronic insomnia patients with an average age of 61 years and 12 healthy controls with an average age of 60 years who were matched for age, sex and education. Insomnia was defined as “chronic” if it had lasted for at least 2.5 years. Participants underwent fMRI scanning during the performance of verbabal fluency tasks between 5 p.m. and 8:30 p.m.

Insomnia patients then were randomly assigned to a six-week long sleep therapy group or a wait-list group. Therapy involved a combination of sleep restriction, multifaceted cognitive-behavior therapy, morning and late afternoon bright-light exposure and body temperature manipulations. After six weeks, fMRI scanning was repeated on both treatment groups during the same verbal fluency tasks.

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Loud snoring and insomnia symptoms predict the development of the metabolic syndrome

A study in the Dec. 1 issue of the journal SLEEP found that loud snoring and two common insomnia symptoms – difficulty falling asleep and unrefreshing sleep – each significantly predicted the development of the metabolic syndrome. The study emphasizes the importance of screening for common sleep complaints in routine clinical practice. Results of multivariate logistic regression models show that the risk of developing the metabolic syndrome over a three-year follow-up period was more than two times higher in adults who reported frequent loud snoring (odds ratio = 2.30). This risk also was increased by 80 percent in adults who reported having difficulty falling asleep (OR = 1.81) and by 70 percent in those who reported that their sleep was unrefreshing (OR = 1.71).

Further analysis found that unrefreshing sleep was reduced to marginal significance with additional adjustment for loud snoring. However, when simultaneously entered in a statistical model, both loud snoring and difficulty falling asleep remained significant independent predictors of the metabolic syndrome.

“This is the first prospective study to show that a broader array of commonly reported sleep symptoms, including insomnia and sleep-disordered breathing symptoms, predict the development of the metabolic syndrome, a key risk factor for cardiovascular disease,” said lead author Wendy M. Troxel, PhD, assistant professor of psychiatry and psychology at the University of Pittsburgh in Pittsburgh, Pa. “It was rather striking that the effects of difficulty falling asleep and loud snoring were largely independent of one another.”

According to the National Heart, Lung, and Blood Institute, metabolic syndrome is a group of obesity-related risk factors that increases an individual’s risk of heart disease, diabetes and stroke. A person with at least three of these five risk factors is considered to have metabolic syndrome: excess abdominal fat, high triglycerides, low HDL cholesterol, high blood pressure and high blood sugar.

Analyses of these five individual components of the metabolic syndrome revealed that loud snoring significantly predicted the development of high blood sugar (OR = 2.15) and low HDL cholesterol (1.92). Difficulty falling asleep and unrefreshing sleep did not predict any of the individual metabolic abnormalities.

Only loud snoring continued to predict the development of the metabolic syndrome after accounting for the number of metabolic abnormalities present at baseline. According to the authors, this suggests that loud snoring may be a causal risk factor cardiometabolic dysregulation.

The study involved 812 participants in Heart SCORE, an ongoing, community-based, prospective study of adults between 45 and 74 years of age. People who were classified as having the metabolic syndrome or diabetes at baseline were excluded form the study. During the three-year follow-up period, 14 percent of participants developed the metabolic syndrome.

Self-reported sleep disturbances were assessed using the Insomnia Symptom Questionnaire and the Multivariable Apnea Prediction Questionnaire. The development of the metabolic syndrome was unrelated to difficulty staying asleep and frequent awakening from sleep, which are two other insomnia symptoms that are commonly reported.

Apnea-hypopnea index (AHI), an average of the combined episodes of partial reductions (hypopneas) and complete pauses (apneas) in breathing per hour of sleep, was calculated in a subset of 290 participants who wore a portable monitor that measured nasal airflow. In an analysis of this subset, loud snoring remained an independent predictor of the development of the metabolic syndrome (OR = 3.01) even after adjusting for AHI, while difficulty falling asleep was reduced to marginal statistical significance.

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Sever Hot Flashes Associated With Chronic Insomnia

Menopause and Insomnia

Women who have severe hot flashes may have more chronic sleep problems than women who do not, according to a report in the June 26 issue of the Archives of Internal Medicine, one of the JAMA/Archives journals.

As many as 85 percent of menopausal women experience hot flashes, sensations of heat that may also involve sweating, according to background information in the article. Hot flashes often occur during the night and have been associated with insomnia, or difficulty sleeping. The symptoms of insomnia include problems falling asleep and/or staying asleep, sleep that is not restful and an overall dissatisfaction with sleep quantity or quality. Because many other factors also influence sleep in menopausal women, the exact link between hot flashes and insomnia has been difficult to establish.

Maurice M. Ohayon, M.D., D.Sc., Ph.D., Stanford University School of Medicine, Palo Alto, Calif., conducted telephone interviews with 3,243 individuals in California, including 982 women ages 35 to 65 years, between June 2003 and April 2004. Of the women, 562 (57.2 percent) were premenopausal; 219 (22.3 percent) were perimenopausal, meaning that they had irregular menstrual cycles with at least one period in the previous year; and 201 (20.5 percent) were postmenopausal, or had reported no menstrual bleeding in the previous year. Hot flashes were defined as mild if they usually did not involve sweating, moderate if they mostly involved sweating but did not require a woman to stop the activity she was pursuing and severe if they typically involved sweating and did require a woman to stop an activity.

About 33 percent of the women reported having hot flashes, including 12.5 percent of the premenopausal women, 79 percent of perimenopausal women and 39.3 percent of postmenopausal women. Of those who had hot flashes, about half reported that they were typically mild, while about one-third had moderate and about 15 percent had severe hot flashes. More than 81 percent of women with regular severe hot flashes had symptoms of chronic insomnia. These women reported difficulty falling asleep, non-restful sleep and overall dissatisfaction with their sleep patterns on a regular basis (at least three nights a week for at least the past six months). Women with mild hot flashes did not report these problems any more frequently than did women with no hot flashes. Women were also more likely to have problems staying asleep as their hot flashes became more severe.

The researchers also examined how insomnia related to women’s menopausal status and found that women in perimenopause were more likely to have difficulty falling asleep, non-restful sleep and overall dissatisfaction with sleep. One-third of perimenopausal and postmenopausal women reported that they believed insomnia was related to the development of menopause.

“This study provides evidence that severe hot flashes are associated with chronic insomnia in women aged 35 to 65 years,” the authors write. “The dramatic increase in insomnia in women with severe hot flashes indicates that severity of hot flashes should be routinely assessed in all studies of menopause.

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