Obstructive Sleep ApneaVAMOSNCT05817123
Validation of the Mutuality Scale in Patients With OSA and Their Partners
An observational study of Obstructive Sleep Apnea, run by Istituto Auxologico Italiano at 1 site in Italy.
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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Questionnaires
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 10 May 2021to 30 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Obstructive Sleep Apnea Syndrome (OSAS) and their partners
Who may be able to join
- Age 18 years and older
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Questionnaires
- Keywords
- Obstructive Sleep Apnea
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
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)
| Study group | Role | What they receive |
|---|---|---|
| OSAS patients | Patients with Obstructive Sleep Apnea Syndrome Receives: Other: Questionnaires | |
| Partners | Partners of OSAS patients Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on Mutuality Scale in OSAS patients
15-item scale; points for every item 0-4; minimum score 0; maximum score 60
Measured: At baseline
Score on Mutuality Scale in partners
15-item scale; points for every item 0-4; minimum score 0; maximum score 60
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start10 May 2021
- Primary completion31 May 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817123
- Sponsor's protocol ID
- 09C123
- Acronym
- VAMOS
- Status last verified
- Feb 2024
- First submitted
- 4 Apr 2023
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychometric Validation of the Mutuality Scale in Patients With Obstructive Sleep Apnea and Their Partners
- ClinicalTrials.gov ID
- NCT05817123
- Acronym / sponsor ID
- VAMOS / 09C123
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive Sleep Apnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 10 May 2021 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OSAS patients | – | Other: QuestionnairesPatients with Obstructive Sleep Apnea Syndrome |
| Partners | – | Other: QuestionnairesPartners of OSAS patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Obstructive Sleep Apnea Syndrome (OSAS) and their partners
Key inclusion criteria (1 listed)
- Age 18 years and older
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesAdministration 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) | Other | OSAS patients, Partners |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by Istituto Auxologico Italiano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score on Mutuality Scale in OSAS patients (time frame: At baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.