Prediction of insomnia in sleep apnea

A prospective observational cohort study to investigate predictors for comorbid insomnia in obstructive sleep apnea.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON24351

Enrollment

400

Registered

2020-09-23

Start date

2020-11-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Insomnia, Obstructive Sleep Apnea

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: • Planned for PSG • Age older than 18 • Speaking and reading Dutch • Be in possession of a computer with internet

Exclusion criteria

Exclusion criteria: • Known allergies for hard plastic (like in sport watches) or elastic band material • Presence of wounds, injuries or infectious diseases on the skin where the wristband will be placed • Tattoo on top of the wrist (where the sensor should be placed) • Pregnancy • Presence of autonomic dysfunction • Having persistent heart rhythm disorders • Conditions which will prevent taking part in questionnaires, for example due to language deficiency • Inability to provide informed consent • Inability to adhere to the study protocol due to severe neurologic or psychiatric disorders • Using alpha-blocking or beta-blocking medication as these may affect heart rate, possibly resulting in unreliable measures of heart rate variability • Currently displaying COVID-19 related symptoms, namely a fever, cough and/or difficulty breathing • Having been positively tested as infected with COVID-19 in the past 14 days • Travelled to or from high risk COVID-19 areas in the past 14 days • Been in contact with a (suspected) COVID-infected person in the past 14 days

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: apnea-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 object 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: * General questionnaire about main complaints * 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: apnea-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 object 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: * General questionnaire about main complaints * Epworth Sleepiness Scale (ESS) * Insomnia Severity Index (ISI) * Hospital Anxiety and Depression Scale (HADS) * Pittsburgh Sleep Quality Index (PSQI) * Pre-Sleep Arousal Scale (PSAS)

—

Contacts

Public ContactBernice Wulterkens

Eindhoven University of Technology

b.m.wulterkens@tue.nl0629147659

Outcome results