Short summary

Insomnia is a the most common sleep disorder characterized by impairment of ability to fall asleep or inability to stay asleep resulting in a lack of healthy rest.

Studies have found effect in children with ADHD and sleeping difficulties using Ball Blankets. However, studies have never been performed with adults to our knowledge.

The aim of this study is to study sleep in patients with insomnia treated with Ball Blankets compared to patients treated with audio therapy.

Rationale

Insomni is the most common sleep disorder. The condition is characterized by difficulty falling asleep or sleeping continuously despite the possibility and that sleep is unable to result in healthy rest. This leads to impairment. The degree of insomnia range from light transient sleep impairment to debilitating chronic conditions. Thus, patients with insomnia suffer from daily limitations due to fatigue and irritability resulting in loss of quality of life. 

In the population, the frequency of insomnia is approximately 10-15%. However, the incidence is significantly higher (50-75%) in pain conditions and psychiatric conditions, while 65% of patients with depression develop insomnia. Calculations have shown that the total cost of insomnia is $ 28 billion annually in the United States. Treatment is divided into pharmacological, including hypnotics with effect on the GABA receptor, melatonin, and benzodiazepines, and non-pharmacological as stimulus control therapy, sleep restriction, relaxation techniques, cognitive strategies and patient education in sleep hygiene. Studies have shown effect on sleep efficiency, sleep latency, unwanted awakening and subjective sleep quality, while the effect on overall sleep time was more uncertain. 

Newer therapies include audio therapy with music. Music is a known tool used as self-therapy to improve sleep. A study has also shown that music therapy is not associated with harmful effects on sleep. However, the full treatment efficiency is not fully understood. It is shown that music can affect the autonomic nervous system and mental factors like mood and concentration. It is thought that slow calming music helps to relax. This is supported by studies that have shown that music can reduce serum levels of cortisol and lead to change of autonomic function such as pulse and blood pressure. Reduction of stress and nervousness is also shown by music treatment. Thus, it is believed that music can affect sleep by promoting relaxation and diverting effect. 

In a study by Hvolby et al. with children diagnosed with ADHD and sleep problems, the effect of treatment with Ball Blankets was demonstrated. The design of the Ball Blanket is based on the American psychologist A. Jean Ayres' theory of sense integration. Sense integration is extremely well-described, where the theories are primarily developed for children and are still being used today. Sensory integration dysfunction leads to inability to process and integrate information from body and environment. Ayres emphasized the importance of "hidden senses", which includes interoception (sensing the body's interior), proprioception (sensing the body's position and movement) and exteroception (sensing the environment on the body). Ayres' theory has been interpreted differently over time and has manifested itself in many treatment modalities. Evidence for the treatment methods is currently low, but research in the field is ongoing. 

Ball Blankets have also been used for psychiatric patients for many years as a sedative method and have in unpublished trials resulted in reduced use of sedatives. 

Hypothesis 

Ball Blankets cause a diffuse effect on the sensory part of the nervous system and may thus inhibit the general activity of the nervous system. They have proven effective in the treatment of sleep problems in patients with ADHD and delirium. Ball Blankets could increase overall sleep time and improve sleep quality in patients with insomnia.

Description of the cohort

Patients with insomnia associated with the sleep clinical at the department of Neurology at Odense University Hospital.

Inclusion criteria:

• Qualify the criteria of the International Classification of Sleep Disorders (ICSD-2) for insomnia.
• Age over 18 years

Exclusion critiria:

• Acute insomnia caused by stress disorder
• Insomnia secondary to psychiatry disorders
• Insomnia induced by medicine or drugs
• Insomnia secondary to illness
• Other known sleep disorders

Data and biological material

Monitoring with actigraphy and questionnaires.

Collaborating researchers and departments

Department of Neurology, Odense University Hospital

• Thomas Krøigård, MD.