Can enhanced insomnia phenotyping aid prediction of treatment response?

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Insomnia is a highly prevalent, complex and heterogeneous disorder. Diagnostically, insomnia is problematic due to a lack of objective markers and with the diagnosis based primarily on patient self-report. Patients with insomnia also have high rates of absenteeism, increased health risks and health-care utilisation, a higher risk of depression and neurocognitive impairments than good sleepers. The main nonpharmacological treatment for insomnia is Cognitive behavioral therapy for insomnia (CBT-I), which is an evidence-based psychological intervention, usually delivered by a psychologist individually, in small groups, or through automated web-based programs. CBT-I seeks to manage insomnia by targeting maladaptive thoughts, behaviors, and beliefs about sleep. CBT-I is a multicomponent approach and in the context of clinical trials improves sleep in 70% of insomnia patients and is considered the first-line treatment for insomnia by the American Academy of Sleep Medicine, National Institutes of Health, and British Association of Psychopharmacology. CBT-I is effective but it does not work for all patients with insomnia. As insomnia is a highly heterogeneous disorder it may be that certain phenotypes of insomnia respond differently to certain components of CBT-I. To date, insomnia phenotyping has focused on subjective clinical impressions by Sleep Physicians or Psychologists to label patients with a chief complaint of either: difficulty initiating sleep, difficulty maintaining sleep, early morning awakenings or mixed insomnia (a combination of at least two of the previously mentioned factors). Currently, there is a lack of objectivity in classifying insomnia phenotypes and evaluating phenotype treatment response to CBT-I. Our aim is to develop phenotyping toolkits to produce an objective diagnostic assessment of insomnia that will assist clinicians to determine the likelihood of an insomnia phenotype responding to treatment (CBT-I). We aim to phenotype all patients for the following three methods including: (A) Classic subjective insomnia phenotyping, diagnosed by a Sleep Physician / Sleep Psychologist interview (based on DSM-V criteria) will be used to identify four insomnia phenotypes characterised by a main complaint of either: (i) difficulty with sleep onset, (ii) difficulty with sleep maintenance, (iii) early morning awakenings, or (iv) mixed insomnia (a combination of at least two previously mentioned main sleep impairments). (B) One in-laboratory overnight polysomnographic assessment of sleep will also be used to quantify insomnia patients with either (i) short objective sleep with both sleep onset and maintenance impairments, (ii) short objective sleep with primarily sleep maintenance impairments, or (iii) long objective sleep. Based on previous results, participants will be assigned to either groups i, ii or iii through a pre-specified algorithm developed from insomnia clustering data (Miller et al., in preparation). (C) One in-laboratory dim light melatonin onset assessment (saliva) will be used to quantify insomnia patients with (i) late phase angle: the most severe 30% of the study sample with the greatest evening phase angle (i.e. melatonin rise after bedtime resulting in a mostly positive phase angle) and a melatonin rise time after 22:00 compared to (ii) normal phase angle: the remaining 70% of the sample. Phase angle onset is defined as the difference between 14 days (minimum of 5 days) of average actigraphy time for bed and the in-laboratory dim light melatonin onset rise time. We primarily aim to evaluate treatment response for these phenotypes of insomnia to standardised online CBT-I for measures of insomnia severity, sleep diary defined sleep onset latency and wake-time after sleep onset. Secondly, we aim to evaluate changes in neurocognition, mood, and actigraphy pre-to-post therapy for insomnia phenotypes. Third, we will compare phenotypes for differences in simulated driving (at 6pm and at one hour after habitual bedtime) and neurocognitive performance (at i. 6pm, ii. habitual bedtime, iii. in the morning after a full sleep opportunity with a patient preferred wake-time and iv. after a reduced sleep opportunity, by going to bed two hours later than average sleep-diary defined habitual bedtime). This study aims to provide evidence of tools to objectively phenotype insomnia by differentiating patients who may or may not respond well to CBT-I prior to the delivery of treatment. In turn, this will facilitate better treatment plans and lead to enhanced sleep, health and daytime performance.

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