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

February 28, 2024 updated by: Istituto Auxologico Italiano

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy
        • Istituto Auxologico Italiano

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with Obstructive Sleep Apnea Syndrome (OSAS) and their partners

Description

OSA patients:

Inclusion Criteria:

  • Age 18 years and older

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
OSAS patients
Patients with Obstructive Sleep Apnea Syndrome
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)
Partners
Partners of OSAS patients
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)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Auxologico Italiano

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2021

Primary Completion (Actual)

May 31, 2022

Study Completion (Actual)

September 30, 2022

Study Registration Dates

First Submitted

April 4, 2023

First Submitted That Met QC Criteria

April 4, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Estimated)

February 29, 2024

Last Update Submitted That Met QC Criteria

February 28, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09C123

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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