--- title: Consequences of Respiratory Devices on Caregivers (CAP2) nct_id: NCT04632836 overall_status: UNKNOWN sponsor: Asten Sante study_type: OBSERVATIONAL primary_condition: Quality of Life countries: France canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04632836.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04632836" ct_last_update_post_date: 2022-07-27 last_seen_at: "2026-05-12T06:33:27.485Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Consequences of Respiratory Devices on Caregivers (CAP2) **Official Title:** Consequences of Respiratory Devices on Caregivers: CAP2 Study **NCT ID:** [NCT04632836](https://clinicaltrials.gov/study/NCT04632836) ## Key Facts - **Status:** UNKNOWN - **Study Type:** OBSERVATIONAL - **Target Enrollment:** 350 - **Lead Sponsor:** Asten Sante - **Conditions:** Quality of Life - **Start Date:** 2021-01-20 - **Completion Date:** 2023-05-01 - **CT.gov Last Update:** 2022-07-27 ## Brief 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 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. ## Eligibility - **Minimum age:** 18 Years - **Sex:** ALL - **Healthy Volunteers:** Yes ``` Inclusion Criteria: 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 * patient followed at Rouen University Hospital For the partner : * patient who consents * patient older than 18 years old Exclusion Criteria: 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 ``` ## Arms - **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) - **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) - **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) ## Interventions - **quality of life questionnaires** (OTHER) — responses for quality of life questionnaires (WHOQOL-BREF questionnaire, study specific questionnaire, PSQI index, HADS scale) ## Primary Outcomes - **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. ## 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)_ ## Locations (1) - Asten Sante, Isneauville, France — _RECRUITING_ ## Recent Field Changes (last 30 days) - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.asten sante|isneauville||france` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT04632836.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT04632836* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*