Sleep Disorders in Children

Research investigators have shown that there is an alternative therapy to the removal of tonsils and adenoids for the relief of mild sleep disordered breathing in children.

In a 16-week study involving 24 young children, researchers employed montelukast, an anti-inflammatory agent used in asthma and allergic rhinitis. They found that the oral therapy resulted in significant reductions in the children’s adenoid size, as well as decreases in respiratory sleep disturbances.

Writing in the American Thoracic Society’s peer-reviewed American Journal of Respiratory and Critical Care Medicine, David Gozal, M.D., along with three associates from Kosair Children’s Hospital Research Institute at the University of Louisville in Louisville, Kentucky, pointed out that the major concept emanating from this study supports the existence of a chronic inflammatory process in children with sleep-disordered breathing.

“Systemic anti-inflammatory agents with safe therapeutic profiles for use in children with sleep-disordered breathing could serve as an alternative intervention to removal of tonsils and adenoids,” said Dr. Gozal.

The 24 children recruited for the study, as well as the 16 controls, were older than age 2, but younger than 10. Each child was a habitual snorer who had been found to have an obstructive apnea-hypopnea index of more than 1, but less than 5 events per hour during overnight polysomnography evaluations at the sleep center.

In obstructive sleep apnea, the sleeping person temporarily stops breathing long enough to decrease oxygen in the blood and build up carbon dioxide. After a breathing pause of 10 seconds or more, the person awakens and resumes breathing.

Obstructive sleep apnea affects 2 to 3 percent of children in the United States. It is usually associated with a blockage in the throat or upper airway. A common symptom is snoring in between pauses in breathing and episodes of awakening. An apnea-hypopnea index (AHI) between 1 and 4 breathing pauses (called “events”) an hour constitutes mild sleep-disordered breathing. Removal of tonsils and adenoids is usually reserved for children whose respiratory index (AHI) during sleep exceeds 5 events per hour of sleep.

In reviewing the research in an editorial in the same issue of the journal, Raanan Arens, M.D., of the Albert Einstein College of Medicine’s Children’s Hospital at Montefiore in Bronx, New York, wrote: “These results, although preliminary, support the notion that obstructive sleep apnea syndrome (OSAS) in children with adenoid and tonsillar hypertrophy has an immunologic/inflammatory component, and that new approaches in reducing inflammation should be considered in children with some forms of OSAS.”

He continued: “If adenotonsillar hypertrophy associated with OSAS is indeed an inflammatory disorder and not just a consequence of excessive physiologic development of these tissues, there is a rationale to use anti-inflammatory modalities for some forms of the disorder. Leukotriene modifiers are especially attractive because they are both safe and effective in other forms of common inflammatory disorders of childhood such as asthma and allergic rhinitis. However, more controlled studies are indicated to assess the efficacy of this group of medications with and without nasal corticosteroids. These future studies will need to address the clinical indications, doses, duration of therapy and recommendations for follow-up of these patients once treatment is discontinued. At this time, the current recommendations to treat children with OSAS remain unchanged and adenotonsillectomy continues to be indicated when adenotonsillar hypertrophy is present. However, it is possible that anti-inflammatory modalities will be introduced in the future for children with mild forms of the disorder as a bridge until surgery is performed, or for a period of time after adenotonsillectomy to suppress any residual inflammation that could continue OSAS symptoms.”

Schering-Plough reported on new study results that demonstrated that Asenapine, a fast-dissolving, sublingual tablet being developed for treatment of schizophrenia, was more effective than placebo and well tolerated in treating patients with acute schizophrenia.

According to the results, asenapine 5 mg twice daily and 10 mg twice daily were both significantly more effective than placebo at improving patient Positive and Negative Syndrome Scale (PANSS) total scores. PANSS is a measure of positive symptoms (e.g., hallucinations and delusions) and negative symptoms (such as lack of emotion expression) associated with acute schizophrenia.

“Patients with schizophrenia and their physicians need to have a variety of treatment options available for the symptoms of this disorder because many patients stop taking their medication,” said John M. Kane, M.D., Chairman of Psychiatry, the Zucker Hillside Hospital in Glen Oaks, NY. “A new therapy that is both effective and well-tolerated would be an important addition to the treatment options currently available.”

Study overview

In the study, 448 adult patients with schizophrenia received either asenapine 5 mg twice daily, asenapine 10 mg twice daily, haloperidol 4 mg twice daily (active comparator), or placebo for six weeks. The primary endpoint was changes in PANSS total score from baseline to day 42.

PANSS score changes were significantly greater for asenapine 5 mg twice daily, asenapine 10 mg twice daily and haloperidol versus placebo (-21.3, – 19.4, -20.0 and -14.6, respectively) based on MMRM analysis (Mixed Model for Repeated Measurements). On secondary efficacy measures, asenapine 5 mg and 10 mg, and haloperidol produced significantly greater reductions in PANSS positive subscale score vs. placebo (-7.5, -6.9 and -7.3 vs. -5.0, respectively). In addition, asenapine 5 mg and 10 mg, and haloperidol demonstrated significant changes to the PANSS negative subscale score vs. placebo (-4.5, -4.3 and -4.2 vs. -3.0, respectively) and on the PANSS general psychopathology subscale score (-9.6, -8.5 and -8.6 vs. -6.8, respectively).

Significantly more patients on both asenapine 5 mg and 10 mg, and haloperidol demonstrated reductions in PANSS total score of greater than or equal to 30 percent (PANSS responders) vs. placebo (55 percent, 49 percent and 43 percent vs. 33 percent, respectively). Changes on the Clinical Global Impression-Severity of Illness (CGI-S) scale for asenapine 5 mg and 10 mg, and haloperidol were higher than for placebo (-1.2 , -1.1 and -1.2 vs. -0.8, respectively).

The most commonly reported adverse events (AEs) were insomnia, oral hypoesthesia (reduced sense of touch), and akathisia (restlessness) for asenapine (for both doses); akathisia, Parkinson-like symptoms, and insomnia for haloperidol. The incidence of clinically-significant weight gain, as well as changes in lipid and blood-sugar levels in this trial were small and not different among the treatment groups and placebo. The incidence of extrapyramidal symptoms reported as an adverse event was 15 percent and 18 percent for asenapine (5 and 10 mg, respectively), 34 percent for haloperidol, and 10 percent for placebo.

The 2007 NSF Sleep in America poll asked respondents about the quality and quantity of sleep. These findings were then analyzed within different biological stages of their lives.

Menstruating women (women of childbearing age) spend an average of 7 hours, 32 minutes in bed on weeknights, with 67% of these women reporting experiencing symptoms of insomnia at least a few nights each week. Of menstruating women:

• 16% say they have missed work one or more days in the past month due to a sleep problem.

 

• 34% say they experience symptoms of a sleep disorder like snoring, sleep apnea and/or RLS.

 

• One-third of menstruating women (33%) say that their sleep is disturbed the week of their cycle.

Pregnant women spend the most hours in bed per weeknight (8 hours, 14 minutes on average), however most pregnant women (84%) report symptoms of insomnia a few nights each week, with 40% also reporting signs of a sleep disorder such as snoring, sleep apnea and/or restless leg syndrome (RLS). Interestingly:

• 30% of pregnant women report that they rarely or never get a good night’s sleep.

 

• Most pregnant women (82%) report getting significantly better sleep before their pregnancy.

 

• One percent of pregnant women report consuming alcohol, beer or wine within an hour of going to bed at least a few nights each week as a sleep aid.

 

• 54% of pregnant women report napping at least twice per week.

Post partum women spend less time in bed on weeknights than pregnant women (7 hours, 46 minutes on average), but they report the same frequency of symptoms of insomnia (84%). Of the women in this group, 42% report that they rarely or never get a good night’s sleep  ” the highest frequency of all the groups.

• When asked what awakens them most during the night, 90% of post partum women say giving care to a child.

 

• Nearly one-half (47%) of post partum women say that they have no one helping them with childcare at night.

 

• 20% of post partum women say they have driven drowsy with children in the car.

 

• 35% of post partum women report experiencing symptoms of a sleep disorder such as snoring, sleep apnea and/or RLS.

 

• Among post partum women with a child who is 3 months old or younger, the child is most often sleeping in a crib in the parent’s room (48%). Roughly one-fourth say their child sleeps in his/her own room (27%) or in the parent’s bed (22%).

 

• About two in ten (19%) women in this category say they experience post partum blues or depression.

Perimenopausal women (women during their menopausal transition years) spend the least amount of time in bed on weeknights of all the groups (7 hours, 12 minutes on average). More than half (59%) of women in this life stage say they experience symptoms of insomnia at least a few nights each week.

• 43% of perimenopausal women report experiencing symptoms of a sleep disorder such as snoring, sleep apnea and/or RLS.

 

• Perimenopausal women cite noise (36%) and co-sleeping pets (20%) as awakening them most during the night. 20% of women in this category say they have a difficult time sleeping due to hot flashes or night sweats at least a few nights each week.

Postmenopausal women generally spend more than 7 hours in bed on weeknights (7 hours, 19 minutes on average), but of all the groups, postmenopausal women report the highest incidence (50%) of a sleep disorder such as snoring, sleep apnea and/or RLS.

• 61% of women in this life stage report experiencing some symptoms of insomnia at least a few nights each week.

 

• 41% say they use a sleep aid at least a few nights per week � � ” the highest frequency of all the groups.

 

• 22% of postmenopausal women say they have a difficult time sleeping due to hot flashes or night sweats. A similar proportion (22%) report experiencing restless legs syndrome (RLS) at least a few nights each week. Symptoms of RLS appear more frequently in these individuals than in other segments.

 

• Postmenopausal women report the highest BMI’s with 36% reporting that they are overweight and 30% that they are obese ” a factor that plays a significant role in sleep disorders.

“Women are often blindsided by life and biology,” said Meir Kryger, MD, director of research and education at the Gaylord Sleep Center and chair of the 2007 NSF Sleep in America poll task force. “As women go through different life stages, internal biological factors and external lifestyle factors have a huge impact on their ability to get a good sleep. Despite the life phase, it’s important for women to choose to make healthy sleep a priority.”

Sleeping and Insomnia Treatment

A recent analysis of national survey data reveals that over 1.6 million American adults use some form of complementary and alternative medicine (CAM) to treat insomnia or trouble sleeping according to scientists at the National Center for Complementary and Alternative Medicine (NCCAM), part of the National Institutes of Health. The data came from the 2002 National Health Interview Survey (NHIS) conducted by the National Center for Health Statistics of the Centers for Disease Control and Prevention.

In 2002 the NHIS, an in-person, annual health survey, included over 31,000 U.S. adults aged 18 years and older. A CAM supplement to the survey asked about the use of 27 types of CAM therapies, as well as a variety of medical conditions for which CAM may be used, including insomnia or trouble sleeping. Survey results show that over 17 percent of adults reported trouble sleeping or insomnia in the past 12 months. Of those with insomnia or trouble sleeping, 4.5 percent – more than 1.6 million people – used some form of CAM to treat their condition.

“These data offer some new insights regarding the prevalence of insomnia or trouble sleeping in the United States and the types of CAM therapies people use to treat these conditions,” said Dr. Margaret A. Chesney, Acting Director of NCCAM. “They will help us develop new research questions regarding the safety and efficacy of the CAM therapies being used.”

Those using CAM to treat insomnia or trouble sleeping were more likely to use biologically based therapies (nearly 65 percent), such as herbal therapies, or mind-body therapies (more than 39 percent), such as relaxation techniques. A majority of people who used herbal or relaxation therapies for their insomnia reported that they were helpful. The two most common reasons people gave for using CAM to treat insomnia were they thought it would be interesting to try (nearly 67 percent) and they thought CAM combined with a conventional treatment would be helpful (nearly 64 percent).

In addition to looking at the data on CAM use and insomnia, the researchers also looked at the connection between trouble sleeping and five significant health conditions: diabetes, hypertension, congestive heart failure, anxiety and depression, and obesity. They found that insomnia or trouble sleeping is highly associated with four of the five conditions: hypertension, congestive heart failure, anxiety and depression, and obesity.

Other key points reported in the analysis include:

 

• Nearly 61 percent reporting trouble sleeping were women versus about 39 percent men.
   
• Insomnia peaks in middle age (45-64 years old) and a second increase appears in people 85 and older.
   
• African Americans and Asians appear less likely to report trouble sleeping or insomnia than whites.
   
• Those with higher education also are less likely to report insomnia or trouble sleeping.

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