Autonomic regulation (aR) in obstructive sleep apnea syndrome (OSAS) with and without type 2 diabetes mellitus (T2D) and a healthy control group.

Recruiting

• Conditions: G47.31; E11.8; E11.9

• Registration Number: DRKS00029604
• Lead Sponsor: Forschungsinstitut Havelhöhe, Berlin, DE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-09
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

OSAS patients with T2D;
OSAS patients without T2D;
healthy control group

Exclusion Criteria

Oncologic disease; depression (= 60 on the VAS); psychosis; other serious illness limiting physical daily function (Karnofsky index = 80%, in control group =90%).

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Trait autonomic regulation (TaR): Global score. <br><br>One-time survey at the beginning of the study

Secondary Outcome Measures

Name	Time	Method
TaR-Subscales; Apnoe-/Hypopnoe Index (AHI); State autonomo Regulation (S-aR), Global score and subscales; Internal Coherence (ICS); Sense of Coherence (SOC-3; plus question 27 from SOC-29); Self-efficacy scale; Self-regualtion Scale, Morning-/evening Typology (Single-Item); Pitthsburgh Sleep Quality Index (PSQI); MOS Short version; SF-12 Life Quality, Hospital Anxiety and Depression Scale (HADS).<br><br> One-time survey at the beginning of the study.