Sleep Homeostasis in Primary Insomnia
Condition: Primary Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      About 10% of the population is believed to suffer from Primary Insomnia. It is also believed
      that people with chronic insomnia have a sleep system that is essentially out of alignment
      (we call this "homeostatic dysregulation"). We also know that a certain form of
      non-medication therapy called cognitive-behavioral therapy is a very effective treatment for
      insomnia. It is not known, however, whether cognitive-behavioral therapy actually works by
      bringing the brain's sleep system back into alignment ("sleep homeostasis"). One of the
      methods used to measure sleep homeostasis is to observe a person's brain waves during sleep
      and particularly during sleep that follows a period of sleep loss.

      The purposes of this study are to first learn whether persons with insomnia do have a
      misaligned sleep system compared to persons who do not have insomnia by assessing the sleep
      of people before and after a period of extended sleep loss. Second, the study will determine
      whether cognitive-behavioral therapy can re-regulate the sleep system and its response to
      sleep loss. Third, the final purpose is to examine whether the immune system of people with
      insomnia is more altered following sleep loss than in the comparison group and whether
      cognitive-behavioral therapy can alter immune function.
    

Detailed description: 
      Despite the magnitude of the problem of Primary Insomnia, and the good efficacy of Cognitive
      Behavioral Treatment for Insomnia (CBT-I), little is known about the pathophysiology of
      insomnia or whether treatment alters the factors that are thought to maintain chronic
      insomnia. Three main factors have been explored as contributing to chronic insomnia:
      hyperarousal, circadian dysrhythmia, and homeostatic dysregulation. Most of the empirical
      work has been related to the role of hyperarousal along three dimensions: somatic, cognitive,
      and cortical.

      The present study is focused on homeostatic abnormalities and secondarily on hyperarousal as
      exhibited in subjects with Primary Insomnia (PIs) compared to Good Sleeper controls (GSs).
      Homeostatic abnormalities will be assessed by evaluating how patients with insomnia respond
      to sleep deprivation.

      This study will use a Modified Sleep Deprivation and Multiple Sleep Latency Test (MSD/MSLT)
      procedure. Response to the procedure will be assessed in terms of sleep continuity, sleep
      architecture and electroencephalographic (EEG) power spectral changes during recovery sleep.
      Hyperarousal will be evaluated using serial measures of somatic (cortisol) and cortical (EEG
      Beta/Gamma activity) arousal across the sleep deprivation protocol.

      These parameters will be evaluated both prior to and following CBT-I in PIs and following an
      equivalent time interval in GSs.
    

Intervention name(s): Cognitive-Behavioral Therapy for Insomnia
Intervention type(s): Behavioral
Intervention description(s): Insomnia Subjects receive CBT-I
Other intervention name(s): Insomnia Subjects receive CBT-I
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Primary Insomnia; Insomnia; Sleep