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NCT05817123 Clinical Trial

Validation of the Mutuality Scale in Patients With OSA and Their Partners

Obstructive Sleep Apnea Clinical Trial

— VAMOS  

Official title:
Psychometric Validation of the Mutuality Scale in Patients With Obstructive Sleep Apnea and Their Partners

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05817123
Other study ID # 09C123
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 10, 2021
Est. completion date September 30, 2022

Study information
Verified date February 2024
Source Istituto Auxologico Italiano
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Main objective of this study is to assess the psychometric characteristics of the Mutuality Scale both in patients with Obstructive Sleep Apnea Syndrome (OSAS) and in their partners-The association between the mutuality score in OSAS patients and their adherence to the use of Continuous Positive Airway Pressure (CPAP) therapy will also be investigated. The results of the study may allow a validation of the Mutuality Score as an instrument for measuring mutuality between OSAS patients and their partners.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date September 30, 2022
Est. primary completion date May 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility OSA patients: Inclusion Criteria: - Age 18 years and older Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Questionnaires
Administration of the following questionnaires: Mutuality scale Pittsburgh Sleep Quality Index (PSQI) Epworth Sleep Scale (ESS) Sleep Condition Indicator (SCI) International Physical Activity Questionaire (IPAQ) Mediterranean diet score (MDS) Quality of Life SF 12 Hospital Anxiety and Depression Scale (HADS)

Locations
Country Name City State
Italy Istituto Auxologico Italiano Milan

Sponsors (1)
Lead Sponsor Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Score on Mutuality Scale in OSAS patients 15-item scale; points for every item 0-4; minimum score 0; maximum score 60 At baseline
Primary Score on Mutuality Scale in partners 15-item scale; points for every item 0-4; minimum score 0; maximum score 60 At baseline
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