Sleep Apnea, ObstructiveCALLSASNCT03537066
CALLSAS Study: Effect of Continuous Positive Airway Pressure Treatment for Obstructive Apnea on Phone Usage Habits
A study testing CPAP in people with Sleep Apnea, Obstructive, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Continuous positive airway pressure (CPAP) treatment improves sleepiness, depression and social activities in patients with obstructive sleep apnea (OSA). This evolution can be captured from changes in phone usage habits coupled with a mobile-based services. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteFrance
- Study dates
- 10 Apr 2018to 15 Jun 2021
- Phase
- Interventional
- 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
Who may be able to join
- Newly diagnosed OSA patients initiated on CPAP
- Follow-up at home by AGIR à dom
- Customers of Orange (or Sosh) for mobile and/or fixed-line telephony for at least 6 months
- Patient who signed a written consent to participate in the study
- Patient affiliated to social security
Who cannot join
- Pregnant women
- Patients with disease not allowing to realize functional and locomotion tests
- Person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure (patient under guardianship or curatorship)
- Patient who, in the judgment of the investigator, may not be cooperative or respectful of the obligations inherent to participation in the study
Trial locations and contacts
1 site in 1 country.
France1 site
Grenoble Alps University Hospital
Grenoble, Auvergne-Rhône-Alpes, 38000
About this study
Official title: Effect of Continuous Positive Airway Pressure Treatment for Obstructive Apnea on Phone Usage Habits: the Callsas Study
Continuous positive airway pressure (CPAP) treatment improves sleepiness, depression and social activities in patients with obstructive sleep apnea (OSA). This evolution can be captured from changes in phone usage habits coupled with a mobile-based services. The aim of this study is to assess the impact of CPAP treatment on phone usage habits in OSA patients.
Read the detailed description
Callsas is a prospective study embarking newly diagnosed obstructive sleep apnea patients initiated to CPAP treatment.
The primary objective is to analyze the modifications in phone usage habits before and after CPAP treatment.
Secondary objectives:
- Correlation between changes in phone usage habits and evolution of sleepiness
- Correlation between changes in phone usage habits and evolution of depression scale
- Correlation between changes in phone usage habits and evolution of quality of life
- Correlation between changes in physical activity measured by phones and evolution of physical activity objectively measured by actigraphy and gait platform
- Correlation between phone usage habits and CPAP adherence
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- CPAP
- 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.
CPAPDevice
All patients included will be treated by CPAP
| Study group | Role | What they receive |
|---|---|---|
| CPAP treatment | Other | All included OSA patients are going to be treated by CPAP Receives: Device: CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of CPAP on phone usage habits indices
Changes in indices of phone usage habits
Measured: from 6 months before CPAP treatment until 6 months after CPAP treatment initiation
Secondary outcomes (7)
Time course evolution of phone usage habits indices and evolution of sleepiness
Assessment of sleepiness by ESS
Measured: from CPAP initiation until 6 months after CPAP treatment initiation
Time course evolution of phone usage habits indices and evolution of depression
Assessment of depression by Pichot scale
Measured: from CPAP initiation until 6 months after CPAP treatment initiation
Time course evolution of phone usage habits indices and evolution of quality of life
Assessment of quality of life by SF-36
Measured: from CPAP initiation until 6 months after CPAP treatment initiation
Time course evolution of phone usage habits indices and evolution of locomotion
patterns of locomotion objectively measured by a gait platform
Measured: from CPAP initiation until 6 months after CPAP treatment initiation
CPAP adherence
Time course evolution of CPAP adherence assessed by telemonitoring versus time course evolution of phone usage habits
Measured: from CPAP initiation until 6 months after CPAP treatment initiation
Access to care as a predictor of CPAP adherence
Care access questionnaire developed by ODENORE and National French insurance
Measured: from CPAP initiation until 6 months after CPAP treatment initiation
Effect of food habit with CPAP treatment
Changes in food frequence questionnaire
Measured: At CPAP initiation and at 6 months after CPAP treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start10 Apr 2018
- Primary completion10 Oct 2018
- Study completion15 Jun 2021
Why it stopped: inability to include subjects on schedule
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Louis PEPIN, Principal investigator, CHU Grenoble Alpes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03537066
- Sponsor's protocol ID
- 2017-A02540-53
- Acronym
- CALLSAS
- Status last verified
- May 2022
- First submitted
- 28 Mar 2018
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Continuous Positive Airway Pressure Treatment for Obstructive Apnea on Phone Usage Habits: the Callsas Study
- ClinicalTrials.gov ID
- NCT03537066
- Acronym / sponsor ID
- CALLSAS / 2017-A02540-53
- Conditions
- Sleep Apnea, Obstructive
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: inability to include subjects on schedule
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 10 Apr 2018 (actual)
- Primary completion
- 10 Oct 2018 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 25 May 2018 (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.
Continuous positive airway pressure (CPAP) treatment improves sleepiness, depression and social activities in patients with obstructive sleep apnea (OSA). This evolution can be captured from changes in phone usage habits coupled with a mobile-based services. The aim of this study is to assess the impact of CPAP treatment on phone usage habits in OSA patients.
Detailed description
Callsas is a prospective study embarking newly diagnosed obstructive sleep apnea patients initiated to CPAP treatment.
The primary objective is to analyze the modifications in phone usage habits before and after CPAP treatment.
Secondary objectives:
- Correlation between changes in phone usage habits and evolution of sleepiness
- Correlation between changes in phone usage habits and evolution of depression scale
- Correlation between changes in phone usage habits and evolution of quality of life
- Correlation between changes in physical activity measured by phones and evolution of physical activity objectively measured by actigraphy and gait platform
- Correlation between phone usage habits and CPAP adherence
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CPAP treatment | Other | Device: CPAPAll included OSA patients are going to be treated by CPAP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Newly diagnosed OSA patients initiated on CPAP
- Follow-up at home by AGIR à dom
- Customers of Orange (or Sosh) for mobile and/or fixed-line telephony for at least 6 months
- Patient who signed a written consent to participate in the study
- Patient affiliated to social security
Key exclusion criteria (4 listed)
- Pregnant women
- Patients with disease not allowing to realize functional and locomotion tests
- Person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure (patient under guardianship or curatorship)
- Patient who, in the judgment of the investigator, may not be cooperative or respectful of the obligations inherent to participation in the study
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 |
|---|---|---|
| CPAPAll patients included will be treated by CPAP | Device | CPAP treatment |
Primary outcome
Effect of CPAP on phone usage habits indices
Time frame: from 6 months before CPAP treatment until 6 months after CPAP treatment initiation
Changes in indices of phone usage habits
7 secondary outcomes
Time course evolution of phone usage habits indices and evolution of sleepiness
Time frame: from CPAP initiation until 6 months after CPAP treatment initiation
Time course evolution of phone usage habits indices and evolution of depression
Time frame: from CPAP initiation until 6 months after CPAP treatment initiation
Time course evolution of phone usage habits indices and evolution of quality of life
Time frame: from CPAP initiation until 6 months after CPAP treatment initiation
Time course evolution of phone usage habits indices and evolution of locomotion
Time frame: from CPAP initiation until 6 months after CPAP treatment initiation
CPAP adherence
Time frame: from CPAP initiation until 6 months after CPAP treatment initiation
Access to care as a predictor of CPAP adherence
Time frame: from CPAP initiation until 6 months after CPAP treatment initiation
Effect of food habit with CPAP treatment
Time frame: At CPAP initiation and at 6 months after CPAP treatment initiation
Results and safety
The study was stopped early (reason given: inability to include subjects on schedule). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Individual participant dataSharing planned: Undecided
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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.
Jean-Louis PEPIN principal investigator
CHU Grenoble Alpes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP in people with Sleep Apnea, Obstructive, run by University Hospital, Grenoble 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 5 inclusion and 4 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: stopped early, as of the sponsor's last update on 24 May 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?
The study was stopped early (reason given: inability to include subjects on schedule). Results are not available in the source record.
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?
Effect of CPAP on phone usage habits indices (time frame: from 6 months before CPAP treatment until 6 months after CPAP treatment initiation). 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 24 May 2022.