Quality of LifeCAP2NCT04632836
Consequences of Respiratory Devices on Caregivers (CAP2)
An observational study of Quality of Life, run by Asten Sante at 1 site in France.
Trial summary
The promoter of the study will conduct a monocentric cohort study that aim to evaluate the consequences of home respiratory devices on patient caregivers' quality of life. The investigators will examine the impact of home respiratory devices on quality of life in general, sleep quality, anxiety and humour depending on… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Quality of Life
- What is being tested?
- quality of life questionnaires
- How many people
- 350 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jan 2021to 1 May 2023
- How long will I take part?
- 1 Week
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Partners of adults patients who have home respiratory devices for chronic obstructive pulmonary disease (COPD), sleep apnea or obesity hypoventilation syndrome or other respiratory insuffisance disease and who share a same household.
Who may be able to join
- For the patient :
- Patient with a diagnostic of chronic obstructive pulmonary disease (COPD), sleep apnea or obesity hypoventilation syndrome
- Home respiratory equipment (NIV, CPAP or LTOT) since more than 3 months, patient and partner who shared the same household
- patient with medical stable condition
- patient who consents
- patient older than 18 years old
Show all 10Show fewer
- patient followed at Rouen University Hospital
- For the partner :
- patient who consents
- patient older than 18 years old
Who cannot join
- For the patient :
- Home respiratory equipment for neuromuscular disease
- Patients who are institutionalized, deprived of their liberty or placed under judicial protection (guardianship or curatorship)
- patient not able to consent
- For the partner :
- Patients who are institutionalized, deprived of their liberty or placed under judicial protection (guardianship or curatorship)
- patient not able to consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Consequences of Respiratory Devices on Caregivers: CAP2 Study
The promoter of the study will conduct a monocentric cohort study that aim to evaluate the consequences of home respiratory devices on patient caregivers' quality of life.
The investigators will examine the impact of home respiratory devices on quality of life in general, sleep quality, anxiety and humour depending on equipment type (Non-invasive ventilation (NIV), continuous positive airway pressure (CPAP) or long-term oxygen therapy (LTOT)) for patients and partners. The investigators will assess the correlation between patient and caregiver's answers. The investigators will assess the correlation between couple's quality of life and adherence to treatment.
To do this, the investigators will use four quality of life questionnaires and the investigators will collect demographic data, medical data and usage report from the equipment.
Read the detailed description
Home respiratory devices improve patients' quality of life and clinical outcomes. However, they bring medical equipment into the bedroom and are used overnight. The aim of this prospective cohort is to assess the quality of life of patient's caregivers.
Patient caregivers' quality of life will be assessed using the WHOQOL-BREF questionnaire (World Health Organization Quality of Life - Brief version questionnaire).
The investigators expect to enroll 200 patients' partners equipped with non-invasive ventilation, 100 patients' partners equipped with continuous positive airway pressure and 50 patients' partners equipped with long-term oxygen therapy. Patients will be recruited from the cohort of patients already established on home treatment and cared for by Asten Santé.
After consent, patient will receive dedicated questionnaires. During a home visit, home healthcare provider technician will retrieve data from the home device.
- Conditions
- Quality of Life
- Being tested
- quality of life questionnaires
- Keywords
- quality of life, Home respiratory equipment, caregivers, Non-invasive ventilation, continuous positive airway pressure, long term oxygen therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quality of life questionnairesOther
responses for quality of life questionnaires (WHOQOL-BREF questionnaire, study specific questionnaire, PSQI index, HADS scale)
| Study group | Role | What they receive |
|---|---|---|
| NIV participant (non invasive-ventilation participant) | From patient:
* demographics data (date of birth, gender, socio-professional category, education level, morphometric data)
* equipment data (type, indication, parameters, observance, usage data),
* medical data (EFR, blood gas, respiratory polygraphy, pulse oxymetry, medical history, smoking status)
* responses of questionnaires (WHOQOL-BREF questionnaire, PSQI index, HADS scale, study specific questionnaire)
From partner:
* demographics data (date of birth, gender, socio-professional category, education level, morphometric data)
* responses of questionnaires (WHOQOL-BREF questionnaire, PSQI index, HADS scale, study specific questionnaire) Receives: Other: quality of life questionnaires | |
| CPAP participant (continuous positive airway pressure participant) | From patient:
* demographics data (date of birth, gender, socio-professional category, education level, morphometric data)
* equipment data (type, indication, parameters, observance, usage data),
* medical data (EFR, blood gas, respiratory polygraphy, pulse oxymetry, medical history, smoking status)
* responses of questionnaires (WHOQOL-BREF questionnaire, PSQI index, HADS scale, study specific questionnaire)
From partner:
* demographics data (date of birth, gender, socio-professional category, education level, morphometric data)
* responses of questionnaires (WHOQOL-BREF questionnaire, PSQI index, HADS scale, study specific questionnaire) Receives: Other: quality of life questionnaires | |
| LTOT participant (long term oxygen therapy participant) | From patient:
* demographics data (date of birth, gender, socio-professional category, education level, morphometric data)
* equipment data (type, indication, parameters, observance, usage data),
* medical data (EFR, blood gas, respiratory polygraphy, pulse oxymetry, medical history, smoking status)
* responses of questionnaires (WHOQOL-BREF questionnaire, PSQI index, HADS scale, study specific questionnaire)
From partner:
* demographics data (date of birth, gender, socio-professional category, education level, morphometric data)
* responses of questionnaires (WHOQOL-BREF questionnaire, PSQI index, HADS scale, study specific questionnaire) Receives: Other: quality of life questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Partner's quality of life score evaluated with WHOQOL-BREF questionnaire (World Health Organization Quality of Life - Brief version questionnaire)
Total quality of life score on WHOQOL-BREF questionnaire (World Health Organization Quality of Life - Brief version questionnaire). This questionnaire contains 26 items and addresses four quality of life domains. Items are rated on a 5-point Likert scale (low score of 1 to high score of 5) to determine a raw item score. The first and the second questions of the questionnaire are examined separately. For the other questions, the mean score for each domain is calculated, resulting in a mean score per domain that is between 4 and 20. Finally, this mean domain score is then multiplied by 4 in order to transform the domain score into a scaled score . For each domain, the minimum domain score is 4 and the maximum domain score is 20. It corresponds to a minimum scaled score of 0 and a maximum scale score of 100 for each domain. A higher score indicating a higher QOL.
Measured: The assessment will take place during the inclusion call (or in the following 10 days, during the respiratory devices provider's visit if the participant was unavailable to answer to the questionnaire during the inclusion call)
Secondary outcomes (11)
Partner's quality of life score evaluated with WHOQOL-BREF questionnaire (World Health Organization Quality of Life - Brief version questionnaire) for each equipment type
Total quality of life score on WHOQOL-BREF questionnaire (World Health Organization Quality of Life - Brief version questionnaire). This questionnaire contains 26 items and addresses four quality of life domains. Items are rated on a 5-point Likert scale (low score of 1 to high score of 5) to determine a raw item score. The first and the second questions of the questionnaire are examined separately. For the other questions, the mean score for each domain is calculated, resulting in a mean score per domain that is between 4 and 20. Finally, this mean domain score is then multiplied by 4 in order to transform the domain score into a scaled score . For each domain, the minimum domain score is 4 and the maximum domain score is 20. It corresponds to a minimum scaled score of 0 and a maximum scale score of 100 for each domain. A higher score indicating a higher QOL.
Measured: The assessment will take place during the inclusion call (or in the following 10 days, during the respiratory devices provider's visit if the participant was unavailable to answer to the questionnaire during the inclusion call)
Patient's quality of life score evaluated with WHOQOL-BREF questionnaire (World Health Organization Quality of Life - Brief version questionnaire) for each equipment type
Total quality of life score on WHOQOL-BREF questionnaire (World Health Organization Quality of Life - Brief version questionnaire). This questionnaire contains 26 items and addresses four quality of life domains. Items are rated on a 5-point Likert scale (low score of 1 to high score of 5) to determine a raw item score. The first and the second questions of the questionnaire are examined separately. For the other questions, the mean score for each domain is calculated, resulting in a mean score per domain that is between 4 and 20. Finally, this mean domain score is then multiplied by 4 in order to transform the domain score into a scaled score . For each domain, the minimum domain score is 4 and the maximum domain score is 20. It corresponds to a minimum scaled score of 0 and a maximum scale score of 100 for each domain. A higher score indicating a higher QOL.
Measured: The assessment will take place during the inclusion call (or in the following 10 days, during the respiratory devices provider's visit if the participant was unavailable to answer to the questionnaire during the inclusion call)
Partner's quality of life evaluated with study specific questionnaire for each equipment type
Total quality of life score on study specific questionnaire. It corresponds with the total score on the study specific questionnaire prepared by the investigators before the study after consulting a committee of experts in the field of chronic respiratory failure and a panel of patients familiar with ventilation according to the Delphi method. This questionnaire assesses five areas of quality of life : sleep, health, married life, social relations and participation in care through the 20 questions considered the most relevant by the panel.
Items are rated on a 10-point Likert scale (low score of 0 to high score of 10) to determine each question score. For each question, the minimum score value is 0 and the maximum score value is 10. The minimum total score value is 0 reflection of a very negative impact of the equipment on the studied domains and the maximum score is 200, reflection of a very positive impact of the equipment.
Measured: The assessment will take place during the inclusion call (or in the following 10 days, during the respiratory devices provider's visit if the participant was unavailable to answer to the questionnaire during the inclusion call)
Patient's quality of life evaluated with study specific questionnaire for each equipment type
Total quality of life score on study specific questionnaire. It corresponds with the total score on the study specific questionnaire prepared by the investigators before the study after consulting a committee of experts in the field of chronic respiratory failure and a panel of patients familiar with ventilation according to the Delphi method. This questionnaire assesses five areas of quality of life : sleep, health, married life, social relations and participation in care through the 20 questions considered the most relevant by the panel.
Items are rated on a 10-point Likert scale (low score of 0 to high score of 10) to determine each question score. For each question, the minimum score value is 0 and the maximum score value is 10. The minimum total score value is 0 reflection of a very negative impact of the equipment on the studied domains and the maximum score is 200, reflection of a very positive impact of the equipment.
Measured: The assessment will take place during the inclusion call (or in the following 10 days, during the respiratory devices provider's visit if the participant was unavailable to answer to the questionnaire during the inclusion call)
Partner's sleep quality evaluated with PSQI index (Pittsburgh Sleep Quality index) for each equipment
Total sleep quality score on PSQI index (Pittsburgh Sleep Quality index). The PSQI score will be expressed as a sub-score for the 7 areas of study and as an overall score (addition of all the sub-scores). For each studied domain, the minimum sub-score is 0 (best quality of sleep) and the maximum sub-score is 3 (worst quality of sleep). An overall score greater than or equal to 5 is a reflection of poor quality of sleep.
Measured: The assessment will take place during the inclusion call (or in the following 10 days, during the respiratory devices provider's visit if the participant was unavailable to answer to the questionnaire during the inclusion call)
Patient's sleep quality evaluated with PSQI index (Pittsburgh Sleep Quality index) for each equipment
Total sleep quality score on PSQI index (Pittsburgh Sleep Quality index). The PSQI score will be expressed as a sub-score for the 7 areas of study and as an overall score (addition of all the sub-scores). For each studied domain, the minimum sub-score is 0 (best quality of sleep) and the maximum sub-score is 3 (worst quality of sleep). An overall score greater than or equal to 5 is a reflection of poor quality of sleep.
Measured: The assessment will take place during the inclusion call (or in the following 10 days, during the respiratory devices provider's visit if the participant was unavailable to answer to the questionnaire during the inclusion call)
Partner's anxiety and humour score evaluated with HADS index (Hospital Anxiety and Depression scale) for each equipment
Total depression and anxiety score on HADS index (Hospital Anxiety and Depression scale). The HADS scale is an instrument used to screen for anxiety and depressive disorders. It has 14 items ranked from 0 to 3. Seven questions relate to anxiety and seven others to the depressive dimension. The score obtained on the HADS scale will be expressed as a score for each area of study:
- the "anxiety score", evaluated by the 7 questions (questions number 1,3,5,7,9,11 and 13)
- the depression score evaluated by the 7 other questions. The total score ranges from 0 to 42 for each participant. For each score (anxiety or depression), a score value of 7 or less corresponds to the absence of anxiety or depression. A score value between 8 and 10 reflects a doubtful symptomatology. A score value more than 11 reflect that the symptomatology is certain.
Measured: The assessment will take place during the inclusion call (or in the following 10 days, during the respiratory devices provider's visit if the participant was unavailable to answer to the questionnaire during the inclusion call)
Patient's anxiety and humour score evaluated with HADS index (Hospital Anxiety and Depression scale) for each equipment
Total depression and anxiety score on HADS index (Hospital Anxiety and Depression scale). The HADS scale is an instrument used to screen for anxiety and depressive disorders. It has 14 items ranked from 0 to 3. Seven questions relate to anxiety and seven others to the depressive dimension. The score obtained on the HADS scale will be expressed as a score for each area of study:
- the "anxiety score", evaluated by the 7 questions (questions number 1,3,5,7,9,11 and 13)
- the depression score evaluated by the 7 other questions. The total score ranges from 0 to 42 for each participant. For each score (anxiety or depression), a score value of 7 or less corresponds to the absence of anxiety or depression. A score value between 8 and 10 reflects a doubtful symptomatology. A score value more than 11 reflect that the symptomatology is certain.
Measured: The assessment will take place during the inclusion call (or in the following 10 days, during the respiratory devices provider's visit if the participant was unavailable to answer to the questionnaire during the inclusion call)
Correlation between patient's answers and partner's answers for each questionnaire
Correlation between patient's answers and partner's answers for WHOQOL-bref questionnaire (World Health Organization Quality of Life - Brief version questionnaire) Correlation between patient's answers and partner's answers for study specific questionnaire Correlation between patient's answers and partner's answers for PSQI index (Pittsburgh Sleep Quality index) Correlation between patient's answers and partner's answers for HADS index (Hospital Anxiety and Depression scale)
Measured: statistics through study completion, an average of 6 months
Correlation between patient's answers and his observance
Correlation between patient's answers for four questionnaires (World Health Organization Quality of Life - Brief version questionnaire, study specific questionnaire, Pittsburgh Sleep Quality index and Hospital Anxiety and Depression scale) and patient's observance data
Measured: statistics through study completion, an average of 6 months
Correlation between partner's answers and patient's observance
Correlation between partner's answers for four questionnaires (World Health Organization Quality of Life - Brief version questionnaire, study specific questionnaire, Pittsburgh Sleep Quality index and Hospital Anxiety and Depression scale) and patient's observance data
Measured: statistics through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start20 Jan 2021
- Primary completion1 May 2023 (estimated)
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Asten Sante
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maxime Patout, Principal investigator, APHP-Sorbonne Université, Service des Pathologies du Sommeil (Département R3S) Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04632836
- Sponsor's protocol ID
- 20-ASTE-01
- Other IDs
- 20.06.11.64653, 2020-A01741-38
- Acronym
- CAP2
- Status last verified
- Jul 2022
- First submitted
- 10 Nov 2020
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All specific individual participant data that underlie results in a publication will be made available upon reasonable request to the principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consequences of Respiratory Devices on Caregivers: CAP2 Study
- ClinicalTrials.gov ID
- NCT04632836
- Acronym / sponsor ID
- CAP2 / 20-ASTE-01
- Conditions
- Quality of Life
- Keywords
- quality of life, Home respiratory equipment, caregivers, Non-invasive ventilation, continuous positive airway pressure, long term oxygen therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Asten SanteIndustry (pharma, biotech, devices)
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 17 Nov 2020 (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.
The promoter of the study will conduct a monocentric cohort study that aim to evaluate the consequences of home respiratory devices on patient caregivers' quality of life.
The investigators will examine the impact of home respiratory devices on quality of life in general, sleep quality, anxiety and humour depending on equipment type (Non-invasive ventilation (NIV), continuous positive airway pressure (CPAP) or long-term oxygen therapy (LTOT)) for patients and partners. The investigators will assess the correlation between patient and caregiver's answers. The investigators will assess the correlation between couple's quality of life and adherence to treatment.
To do this, the investigators will use four quality of life questionnaires and the investigators will collect demographic data, medical data and usage report from the equipment.
Detailed description
Home respiratory devices improve patients' quality of life and clinical outcomes. However, they bring medical equipment into the bedroom and are used overnight. The aim of this prospective cohort is to assess the quality of life of patient's caregivers.
Patient caregivers' quality of life will be assessed using the WHOQOL-BREF questionnaire (World Health Organization Quality of Life - Brief version questionnaire).
The investigators expect to enroll 200 patients' partners equipped with non-invasive ventilation, 100 patients' partners equipped with continuous positive airway pressure and 50 patients' partners equipped with long-term oxygen therapy. Patients will be recruited from the cohort of patients already established on home treatment and cared for by Asten Santé.
After consent, patient will receive dedicated questionnaires. During a home visit, home healthcare provider technician will retrieve data from the home device.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NIV participant (non invasive-ventilation participant) | – | Other: quality of life questionnairesFrom patient: * demographics data (date of birth, gender, socio-professional category, education level, morphometric data) * equipment data (type, indication, parameters, observance, usage data), * medical data (EFR, blood gas, respiratory polygraphy, pulse oxymetry, medical history, smoking status) * responses of questionnaires (WHOQOL-BREF questionnaire, PSQI index, HADS scale, study specific questionnaire) From partner: * demographics data (date of birth, gender, socio-professional category, education level, morphometric data) * responses of questionnaires (WHOQOL-BREF questionnaire, PSQI index, HADS scale, study specific questionnaire) |
| CPAP participant (continuous positive airway pressure participant) | – | Other: quality of life questionnairesFrom patient: * demographics data (date of birth, gender, socio-professional category, education level, morphometric data) * equipment data (type, indication, parameters, observance, usage data), * medical data (EFR, blood gas, respiratory polygraphy, pulse oxymetry, medical history, smoking status) * responses of questionnaires (WHOQOL-BREF questionnaire, PSQI index, HADS scale, study specific questionnaire) From partner: * demographics data (date of birth, gender, socio-professional category, education level, morphometric data) * responses of questionnaires (WHOQOL-BREF questionnaire, PSQI index, HADS scale, study specific questionnaire) |
| LTOT participant (long term oxygen therapy participant) | – | Other: quality of life questionnairesFrom patient: * demographics data (date of birth, gender, socio-professional category, education level, morphometric data) * equipment data (type, indication, parameters, observance, usage data), * medical data (EFR, blood gas, respiratory polygraphy, pulse oxymetry, medical history, smoking status) * responses of questionnaires (WHOQOL-BREF questionnaire, PSQI index, HADS scale, study specific questionnaire) From partner: * demographics data (date of birth, gender, socio-professional category, education level, morphometric data) * responses of questionnaires (WHOQOL-BREF questionnaire, PSQI index, HADS scale, study specific questionnaire) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Partners of adults patients who have home respiratory devices for chronic obstructive pulmonary disease (COPD), sleep apnea or obesity hypoventilation syndrome or other respiratory insuffisance disease and who share a same household.
Key inclusion criteria (10 listed)
- Patient with a diagnostic of chronic obstructive pulmonary disease (COPD), sleep apnea or obesity hypoventilation syndrome
- Home respiratory equipment (NIV, CPAP or LTOT) since more than 3 months, patient and partner who shared the same household
- patient with medical stable condition
- patient who consents
- patient older than 18 years old
Key exclusion criteria (7 listed)
- Home respiratory equipment for neuromuscular disease
- Patients who are institutionalized, deprived of their liberty or placed under judicial protection (guardianship or curatorship)
- patient not able to consent
- Patients who are institutionalized, deprived of their liberty or placed under judicial protection (guardianship or curatorship)
- patient not able to consent
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 |
|---|---|---|
| quality of life questionnairesresponses for quality of life questionnaires (WHOQOL-BREF questionnaire, study specific questionnaire, PSQI index, HADS scale) | Other | CPAP participant (continuous positive airway pressure participant), LTOT participant (long term oxygen therapy participant), NIV participant (non invasive-ventilation participant) |
Primary outcome
Partner's quality of life score evaluated with WHOQOL-BREF questionnaire (World Health Organization Quality of Life - Brief version questionnaire)
Time frame: The assessment will take place during the inclusion call (or in the following 10 days, during the respiratory devices provider's visit if the participant was unavailable to answer to the questionnaire during the inclusion call)
Total quality of life score on WHOQOL-BREF questionnaire (World Health Organization Quality of Life - Brief version questionnaire). This questionnaire contains 26 items and addresses four quality of life domains. Items are rated on a 5-point Likert scale (low score of 1 to high score of 5) to determine a raw item score. The first and the second questions of the questionnaire are examined separately. For the other questions, the mean score for each domain is calculated, resulting in a mean score per domain that is between 4 and 20. Finally, this mean domain score is then multiplied by 4 in order to transform the domain score into a scaled score . For each domain, the minimum domain score is 4 and the maximum domain score is 20. It corresponds to a minimum scaled score of 0 and a maximum scale score of 100 for each domain. A higher score indicating a higher QOL.
11 secondary outcomes
Partner's quality of life score evaluated with WHOQOL-BREF questionnaire (World Health Organization Quality of Life - Brief version questionnaire) for each equipment type
Time frame: The assessment will take place during the inclusion call (or in the following 10 days, during the respiratory devices provider's visit if the participant was unavailable to answer to the questionnaire during the inclusion call)
Patient's quality of life score evaluated with WHOQOL-BREF questionnaire (World Health Organization Quality of Life - Brief version questionnaire) for each equipment type
Time frame: The assessment will take place during the inclusion call (or in the following 10 days, during the respiratory devices provider's visit if the participant was unavailable to answer to the questionnaire during the inclusion call)
Partner's quality of life evaluated with study specific questionnaire for each equipment type
Time frame: The assessment will take place during the inclusion call (or in the following 10 days, during the respiratory devices provider's visit if the participant was unavailable to answer to the questionnaire during the inclusion call)
Patient's quality of life evaluated with study specific questionnaire for each equipment type
Time frame: The assessment will take place during the inclusion call (or in the following 10 days, during the respiratory devices provider's visit if the participant was unavailable to answer to the questionnaire during the inclusion call)
Partner's sleep quality evaluated with PSQI index (Pittsburgh Sleep Quality index) for each equipment
Time frame: The assessment will take place during the inclusion call (or in the following 10 days, during the respiratory devices provider's visit if the participant was unavailable to answer to the questionnaire during the inclusion call)
Patient's sleep quality evaluated with PSQI index (Pittsburgh Sleep Quality index) for each equipment
Time frame: The assessment will take place during the inclusion call (or in the following 10 days, during the respiratory devices provider's visit if the participant was unavailable to answer to the questionnaire during the inclusion call)
Partner's anxiety and humour score evaluated with HADS index (Hospital Anxiety and Depression scale) for each equipment
Time frame: The assessment will take place during the inclusion call (or in the following 10 days, during the respiratory devices provider's visit if the participant was unavailable to answer to the questionnaire during the inclusion call)
Patient's anxiety and humour score evaluated with HADS index (Hospital Anxiety and Depression scale) for each equipment
Time frame: The assessment will take place during the inclusion call (or in the following 10 days, during the respiratory devices provider's visit if the participant was unavailable to answer to the questionnaire during the inclusion call)
Correlation between patient's answers and partner's answers for each questionnaire
Time frame: statistics through study completion, an average of 6 months
Correlation between patient's answers and his observance
Time frame: statistics through study completion, an average of 6 months
Correlation between partner's answers and patient's observance
Time frame: statistics through study completion, an average of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- Individual participant dataSharing planned: Yes. All specific individual participant data that underlie results in a publication will be made available upon reasonable request to the principal investigator
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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.
Maxime Patout principal investigator
APHP-Sorbonne Université, Service des Pathologies du Sommeil (Département R3S) Paris, France
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 Quality of Life, run by Asten Sante at 1 site in France.
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 10 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 27 Jul 2022. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Johan Dupuis (+33789207533, jdupuis@astensante.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Partner's quality of life score evaluated with WHOQOL-BREF questionnaire (World Health Organization Quality of Life - Brief version questionnaire) (time frame: The assessment will take place during the inclusion call (or in the following 10 days, during the respiratory devices provider's visit if the participant was unavailable to answer to the questionnaire during the inclusion call)). 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 27 Jul 2022; AzTrials last refreshed its copy on 6 Nov 2026.