CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


SleepioWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (0)


Name (Synonyms) Correlation

Correlated MeSH Terms (3)


Name (Synonyms) Correlation
D007319 Sleep Initiation and Maintenance Disorders NIH 0.58
D011618 Psychotic Disorders NIH 0.50
D001523 Mental Disorders NIH 0.21

Correlated HPO Terms (2)


Name (Synonyms) Correlation
HP:0100785 Insomnia HPO 0.58
HP:0000709 Psychosis HPO 0.50

There is one clinical trial.

Clinical Trials


1 Randomised Study of Web-based CBT Intervention (Sleepio) to Reduce Insomnia and Improve Social Recovery in Early Psychosis (CRISP)

Sleep disturbances and cognitive dysfunction are consistently reported as extremely troublesome aspects of psychotic illnesses. While sleep disturbances are not included in definitions of psychosis they are associated with poor levels of daily function and impaired social recovery. Despite sleep problems being documented as co-occurring with psychosis, sleep remains unexamined as a potential therapeutic target pathway for social recovery. Specific areas of cognition are known to be associated with psychosis, sleep deficits and daily function, yet these have not been tested as possible mediators of the association between improved sleep and better daily function and social recovery. This study will examine the relationship between sleep quality, daily function and ultimately social recovery in early psychosis. A secondary aim will examine whether specified areas of cognition (i.e. attention, memory, executive function, social and emotional recognition) mediate the proposed association between sleep and social recovery. Participants will have experienced a first episode psychosis and be currently engaged with CAMEO early intervention, in Cambridgeshire and Peterborough NHS Foundation Trust (CPFT). Cameo is a service for people aged 14-65 years old who are experiencing symptoms of psychosis for the first time (http://www.cameo.nhs.uk). A publicly available, online intervention based on cognitive behavioural therapy (CBT) for insomnia (Sleepio) will be utilised to improve sleep. Participants will be randomised to receive the intervention + treatment as usual (TAU) through their CAMEO team or TAU alone over an eight-week period. The entire study will last for seventeen weeks including an eight-week follow-up period.

NCT04180709 Psychotic Disorders Psychosis Sleep Device: Sleepio
MeSH:Sleep Initiation and Maintenance Disorders Psychotic Disorders Mental Disorders
HPO:Insomnia Psychosis

Primary Outcomes

Description: WSAS is a simple and reliable measure of impaired functioning. Scores range from 0-40, with lower scores representing better functioning, scores 0-10 are considered subclinical, 11-20 associated with significant functional impairment but less severe clinical symptomology, and >20 suggest moderately severe functional impairment (Mundt et al. 2002).

Measure: Change from baseline Work and Social Adjustment Scale (WSAS) score at week 9 of study

Time: Measure completed at baseline (start of week 1) and week 9.

Secondary Outcomes

Description: Social recovery will be measured using an adapted versions of the Time Use Survey (TUS) Structured Hours, which has been previously validated for use as a social recovery measure by Hodgekins, Fowler and colleagues, and utilised in the National EDEN study (Hodgekins et al. 2015; Hodgekins 2012; Fowler et al. 2009). This will be adapted to a reduced interview to include only those areas relevant to the social recovery measure, hence the Time Use Survey-Structured Hours (TUS-SH).

Measure: Time Use Survey - Structured Hours (TUS-SH)

Time: Measure completed in weeks 1, 5, 9, 13 and 17.

Description: PHQ-9 is a self-administered measure of depression, which scores all 9 of the DSM-IV criteria for depression. Scores range from 0-27, with 5-9 indicating minimal symptoms, 10-14 minor depression, 15-19 moderately severe major depression and ≥20 severe major depression.

Measure: Patient Health Questionnaire (PHQ-9)

Time: Measure completed in weeks 1, 5, 9, 13 and 17.

Description: iPad delivered cognitive test of sustained attention.

Measure: Rapid Visual Information Processing (RVP) / CANTAB Cognitive Test

Time: Measure completed in weeks 1, 5, 9, 13 and 17.

Description: iPad delivered cognitive test of visual episodic memory.

Measure: Paired Associates Learning (PAL) / CANTAB Cognitive Test

Time: Measure completed in weeks 1, 5, 9, 13 and 17.

Description: iPad delivered cognitive test of working memory and strategy.

Measure: Spatial Working Memory (SWM) / CANTAB Cognitive Test

Time: Measure completed in weeks 1, 5, 9, 13 and 17.

Description: iPad delivered cognitive test of emotional recognition.

Measure: Emotion Recognition Task (ERT) / CANTAB Cognitive Test

Time: Measure completed in weeks 1, 5, 9, 13 and 17.

Description: GAF is an assessment of psychological, social and occupational functioning along a hypothetical continuum of mental health/illness. It is suggested that symptom scale for degree of severity be considered to cover the past 3 days prior to assessment but time frames can be varied based on the intention of use (Aas 2011). However by utilising the split version of this measure, the symptom and function scores can be evaluated and considered independently. This has been shown to be highly consistent across experienced raters, so sufficient training and utilisation may be fundamental to its efficacy (Pedersen et al. 2007). Scores range from 0-100 with higher scores representing better functioning across symptomatic and functional domains (Hall 1995).

Measure: Global Assessment of Functioning (GAF) (split version / subscales GAF-D & GAF-S)

Time: Measure completed in weeks 1, 9 and 17.

Description: WSAS is a simple and reliable measure of impaired functioning. Scores range from 0-40, with lower scores representing better functioning, scores 0-10 are considered subclinical, 11-20 associated with significant functional impairment but less severe clinical symptomology, and >20 suggest moderately severe functional impairment (Mundt et al. 2002).

Measure: Change from baseline Work and Social Adjustment Scale (WSAS) score at week 17

Time: Measure completed at baseline (start of week 1) and week 17.

Description: WSAS is a simple and reliable measure of impaired functioning. Scores range from 0-40, with lower scores representing better functioning, scores 0-10 are considered subclinical, 11-20 associated with significant functional impairment but less severe clinical symptomology, and >20 suggest moderately severe functional impairment (Mundt et al. 2002).

Measure: Change from baseline Work and Social Adjustment Scale (WSAS) score at week 5, to correct for confounding in mediation analysis

Time: Measure completed at baseline (start of week 1) and week 5.

Description: WSAS is a simple and reliable measure of impaired functioning. Scores range from 0-40, with lower scores representing better functioning, scores 0-10 are considered subclinical, 11-20 associated with significant functional impairment but less severe clinical symptomology, and >20 suggest moderately severe functional impairment (Mundt et al. 2002).

Measure: Change from baseline Work and Social Adjustment Scale (WSAS) score at week 13, to correct for confounding in mediation analysis

Time: Measure completed at baseline (start of week 1) and week 13.

Other Outcomes

Description: SCI-8 this measure is validated against DSM-5 criteria for insomnia, including sleep quality and daytime function over the previous week. It is utilised within the Sleepio intervention and was the primary outcome measure for the OASIS randomised controlled trial (Freeman et al. 2017). This eight-item assessment questionnaire includes: 'concerns about getting to sleep, remaining asleep, sleep quality, daytime functioning, daytime performance, duration of sleep problem, nights per week having a sleep problem and extent troubled by poor sleep'(Espie, Kyle, Hames, et al. 2014). It has a robust internal consistency (α≥0.86) and showed convergent validity with the Pittsburgh Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI) (Espie, Kyle, Hames, et al. 2014). Scores range from 0-32 with higher scores indicating better sleep, scores below 17 identifying insomnia in 89% of cases (Espie, Kyle, Hames, et al. 2014; Freeman et al. 2017).

Measure: Sleep Condition Indicator (SCI-8)

Time: Measure completed in weeks 1, 5, 9, 13 and 17.

Description: ISI is a measure specifically designed as a brief self-administered measure of insomnia and outcomes for use in their treatment within research. It corresponds to the DSM-IV criteria for insomnia and measures perception and severity of symptoms within the previous 2 weeks. Scores range from 0-28, 0-7 indicating no significant insomnia, 8-14 sub threshold insomnia, 15-21 moderate clinical insomnia, and 22-28 severe clinical insomnia (Smith & Wegener 2003; Bastien et al. 2001). It has been validated as a web-based measure with internal consistency of ≥88% (Thorndike et al. 2011).

Measure: Insomnia Severity Index (ISI)

Time: Measure completed in weeks 1, 9 and 17.

Description: PSQI is a self-report 19-item measure that retrospectively measures sleep quality and disturbances over the previous month. The domains of sleep quality included are: sleep wake patterns, duration of sleep, sleep latency, the frequency and severity of specific sleep-related problems and impact on daytime function. Scores range from 0-21, with higher scores indicating poorer sleep quality. The empirically derived cut-off score is >5 to distinguish poor sleepers with severe difficulties in at least 2 domains, or moderate difficulties in more than 3 domains. This cut-off correctly identifies 88.5% of patients, with a sensitivity of 89.6% and specificity of 86.5% (Buysse et al. 1989; Smith & Wegener 2003).

Measure: Pittsburgh Sleep Quality Index (PSQI)

Time: Measure completed in weeks 1, 9 and 17.

Description: Nightly sleep diaries will be reported online using the Sleepio.com online diary. GENEActive actigraphy watch will collect raw data of activity. Which will record sleep patterns objectively. This will be compared with sleep diaries for consistency of subjective measure with objective measure. The actigraphy data will be considered for L5 (lowest 5 hours of activity) M10 (highest 10 hours of activity) and relative amplitude (ratio between L5 and M10). This will then be compared with the nightly sleep diaries for the same period to determine percentage of consistency of reporting.

Measure: Validation of Sleep Diaries by comparison with actigraphy activity data

Time: Monitoring will be done for a complete week just prior to week 1, during week 8 and 16. Sleep diaries are collected nightly during this same period.

Description: This is a short 7 question (3 minute) survey to allow us to collect basic data on the impact of the ongoing pandemic on participants.

Measure: COVID-19 Brief Questionnaire (COVID-19-B)

Time: Measure completed in weeks 1, 5, 9, 13 and 17.


Related HPO nodes (Using clinical trials)