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OpenTrials
Completed

NCT Number: NCT05817123

Validation of the Mutuality Scale in Patients With OSA 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Auxologico Italiano

Milan, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

OSA patients:

Inclusion criteria

  • Age 18 years and older

Exclusion criteria

-

Treatment and study plan

questionnaires

Other

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)

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Istituto Auxologico Italiano

Other

Registry information

Official study title

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

Acronym: VAMOS

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 18, 2023
Registry last updated
Feb 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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