Registry Study of Saarland University Medical Center on the Multidimensional Assessment of Disease Course and Quality of Life in Patients with Sleep Disorders and Disorders Associated with Excessive Daytime Sleepiness

Registry Study of Saarland University Medical Center on the Multidimensional Assessment of Disease Course and Quality of Life in Patients with Sleep Disorders and Disorders Associated with Excessive Daytime Sleepiness - UNISAAR-SLEEPREG

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00041101

Enrollment

2500

Registered

2026-07-24

Start date

2025-10-01

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Sleep Disorders and Disorders Associated with Excessive Daytime Sleepiness

Interventions

Group 1: This registry study is designed to characterize the longitudinal clinical course of patients with sleep disorders and disorders associated with excessive daytime sleepiness. A multidimensiona

Eligibility

Sex/Gender

All

Age

7 Years to No maximum

Inclusion criteria

Inclusion criteria: - Patients with a diagnosis of a sleep disorder (including insomnia and parasomnias) - Patients with disorders associated with excessive daytime sleepiness, including sleep-related breathing disorders, narcolepsy, and other central disorders of hypersomnolence - Written informed consent provided by the patient or, where applicable, by the patient's parent(s), legal guardian, or legally authorized representative

Exclusion criteria

Exclusion criteria: - Age <7 years - Patients unable to provide informed consent who do not have a legally authorized representative

Design outcomes

Primary

Measure	Time frame
Longitudinal changes in sleep quality as assessed by the Insomnia Severity Index (ISI), daytime sleepiness as measured by the Epworth Sleepiness Scale (ESS), and quality of life as assessed by the EuroQol (EQ-5D/EQ-VAS) and the WHOQOL-BREF. Data will be collected at 3, 6, 12, 18, and 24 months after enrollment, followed by annual assessments for an additional three years. Data collection will be based on structured interviews and verified against the patients' medical records.	—

Measure

Time frame

Longitudinal changes in sleep quality as assessed by the Insomnia Severity Index (ISI), daytime sleepiness as measured by the Epworth Sleepiness Scale (ESS), and quality of life as assessed by the EuroQol (EQ-5D/EQ-VAS) and the WHOQOL-BREF. Data will be collected at 3, 6, 12, 18, and 24 months after enrollment, followed by annual assessments for an additional three years. Data collection will be based on structured interviews and verified against the patients' medical records.

—

Secondary

Measure	Time frame
Beck Depression Inventory II; Multidimensional Fatigue Inventory; Ullanlinna Narcolepsy Scale; Multidimensional Fatigue Inventory; Pittsburgh Sleep Quality Index (PSQI); Resilienzskala (Kurzform RS-13); Berlin Social Support Scale. Data will be collected at 3, 6, 12, 18, and 24 months after enrollment, followed by annual assessments for an additional three years.	—

Countries

Germany

Contacts

Public ContactYaroslav Winter

Universitätsklinikum des Saarlandes

yaroslav.winter@uks.eu+4968411614107

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026