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The impact of insomnia treatment on cardiovascuklar risk factors - a randomised controlled trial

The impact of insomnia treatment on cardiovascuklar risk factors - a randomised controlled trial - INSOMNIE-KARDIO

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00007128
Enrollment
50
Registered
2014-10-30
Start date
2015-03-04
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

F51.0

Interventions

Group 1: Eight weekly individual sessions of cognitive behavioural treatment for insomnia with a duration of 50 min each Group 2: waitlist control condition

Sponsors

Universitätsklinikum Freiburg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) Primary insomnia according to the research diagnostic criteria (Edinger et al., 2004), 2) age 18-65 years, 3) informed written consent.

Exclusion criteria

Exclusion criteria: 1) comorbid psychiatric disorders, 2) comorbid sleep disorders, 3) psychotropic medication, 4) Shift work or transmeridian flights within four weeks prior to study inclusion and during study participation, 5) suicidality, 6) previous treatment with cognitive behavioural therapy for insomnia, 7) heart failure NYHA II-IV, 8) patients with heart transplants, 9) infectious diseases, 10) cancer, 11) chronic kidney disease

Design outcomes

Primary

MeasureTime frame
Systolic blood pressure, diastolic blood pressure, heart rate variability parameters (LF/HF, SDNN), heart rate will be measured at baseline (pre-treatment) and 8 weeks later (post-treatment)

Secondary

MeasureTime frame
AFTER the study was conducted and published, it makes no sense to name secondary outcomes.

Countries

Germany

Contacts

Public ContactKai Spiegelhalder

Universitätsklinikum Freiburg, Klinik für Psychiatrie und Psychotherapie

Kai.Spiegelhalder@uniklinik-freiburg.de0761/27065890

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026