A prospective observational cohort study to investigate predictors for comorbid insomnia in obstructive sleep apnea (COMISA)

A prospective observational cohort study to investigate predictors for comorbid insomnia in obstructive sleep apnea (COMISA) - Prediction of insomnia in sleep apnea

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49679

Enrollment

400

Registered

2021-01-19

Start date

2021-04-01

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

slaapstoornissen OSA and insomnia

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Referred to Sleep Center Amphia for suspected OSA Planned for polysomnography Be in possession of a computer with internet

Exclusion criteria

Exclusion criteria: Pregnancy Autonomic dysfunction (e.g. Parkinson's disease) Persistent heart rhythm disorders (e.g. Atrium Fibrillation) Use of alpha- and/or beta-blockers

Design outcomes

Primary

Measure	Time frame
Demographic parameters: age, gender, BMI Polysomnography derived parameters: * macrostructural sleep parameters * number of apnea/hypopnea events per hour of sleep: apena-hypopnea index (AHI) * oxygen saturation Sleep diary derived parameters: * subjective macrostructural parameters * night-to-night variability of sleep parameters * estimators of misperception and other comparisons between objective and subjective sleep data Sleep disorders diagnosis: OSA, COMISA, insomnia, other CPAP compliance (read out from CPAP device): * number of hours the CPAP device has been used * AHI PPG and accelerometry derived parameters: * macrostructural sleep parameters * night-to-night variability of sleep parameters Questionnaires: * Epworth Sleepiness Scale (ESS) * Insomnia Severity Index (ISI) * Hospital Anxiety and Depression scale (HADS) * Pittsburgh Sleep Quality Index (PSQI) * Pre-Sleep Arousal Scale (PSAS)	—

Measure

Time frame

Demographic parameters: age, gender, BMI Polysomnography derived parameters: * macrostructural sleep parameters * number of apnea/hypopnea events per hour of sleep: apena-hypopnea index (AHI) * oxygen saturation Sleep diary derived parameters: * subjective macrostructural parameters * night-to-night variability of sleep parameters * estimators of misperception and other comparisons between objective and subjective sleep data Sleep disorders diagnosis: OSA, COMISA, insomnia, other CPAP compliance (read out from CPAP device): * number of hours the CPAP device has been used * AHI PPG and accelerometry derived parameters: * macrostructural sleep parameters * night-to-night variability of sleep parameters Questionnaires: * Epworth Sleepiness Scale (ESS) * Insomnia Severity Index (ISI) * Hospital Anxiety and Depression scale (HADS) * Pittsburgh Sleep Quality Index (PSQI) * Pre-Sleep Arousal Scale (PSAS)

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Countries

Netherlands

Outcome results