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

Not Applicable

• Conditions: F51.0; Nonorganic insomnia

• Registration Number: DRKS00007128
• Lead Sponsor: niversitätsklinikum Freiburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-30
• Study Completion: 2017-07-31
• Results First Posted: 2020-06-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 46

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
AFTER the study was conducted and published, it makes no sense to name secondary outcomes.