The Treatment of Insomnia Comorbid With Sleep Disordered Breathing Using Armodafinil and/or Cognitive Behavioral Therapy for Insomnia
Condition: Sleep Apnea; Insomnia
MeSH terms: Sleep Apnea Syndromes; Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to assess the effects of Armodafinil, CBT-I, or the combination
      of the two on the sleep continuity of persons suffering from sleep disordered breathing and
      their adherence to CBT-I and Continuous Positive Airway Pressure (CPAP). Adults diagnosed
      with obstructive sleep apnea and who meet additional research and diagnostic criteria for
      insomnia will be recruited. Participants will submit daily sleep diaries and supplemental
      questionnaires as measures of study progress.
    

Detailed description: 
      Rationale:

      Insomnia and sleep disordered breathing are the most common sleep disorders and they tend to
      be highly comorbid. When they co-occur, not only is there an increase in cumulative
      morbidity, but it is likely that these two diseases interact to: promote overall greater
      illness severity; reduce treatment adherence; and diminish treatment efficacy. The results
      from the proposed project will provide valuable information on how co-treatment for these two
      disorders can promote improved sleep quantity, enhanced sleep quality, better compliance with
      Positive Airway Pressure (PAP) therapy, and better daytime functioning.

      Background:

      There is now substantial evidence that Cognitive Behavioral Therapy for Insomnia (CBT-I) is
      efficacious for Primary Insomnia (PI), that it is as potent as sedative hypnotic treatment,
      and better sustained over time. Further, there is now increasing evidence that CBT-I can be
      applied to insomnias that are co-morbid with medical and psychiatric disorders, and with
      equal efficacy. The evidence for an expanded indication, to date, has been for insomnia
      comorbid with depression, chronic pain, and cancer. Interestingly, there are very few studies
      on the efficacy of CBT-I in insomnia comorbid with other intrinsic sleep disorders, including
      in patients with Sleep Disordered Breathing (SDB). This is surprising given that insomnia
      frequently occurs comorbidly with SDB. It is estimated that 40-60% of patients with SDB also
      suffer from insomnia. The lack of data regarding the applicability of CBT-I to insomnia
      co-morbid with SDB is likely due to the concern that CBT-I will be difficult to tolerate in
      patients with insomnia co-morbid with SDB given the treatment's tendency to produce acute
      increases in fatigue, sleepiness, and transient reductions in attention and performance.
      Accordingly, the investigators of this study propose to conduct a randomized, controlled
      trial on the effects of Armodafinil alone and in combination with CBT-I in patients with
      Insomnia comorbid with SDB.

      Note: The choice to evaluate Armodafinil as both a monotherapy and an adjuvant therapy to
      CBT-I for insomnia has a firm conceptual basis and is supported by preliminary data from our
      group. The choice to evaluate Armodafinil in patients with insomnia co-morbid with SDB is
      further supported by the existing indication for sleepiness in patients with SDB.
    

Intervention name(s): Cognitive Behavioral Therapy for Insomnia; Armodafinil; Placebo
Intervention type(s): Behavioral; Drug; Drug
Intervention description(s): Cognitive Behavioral Therapy for Insomnia.; Active medication; Placebo for Nuvigil (armodafinil)
Other intervention name(s): CBT-I; NuVigil
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment