Sleep Apnea SyndromesNCT03446560
Cloud Based Follow up of CPAP Treatment
A study testing CPAP, conventional follow up and CPAP, telemedicine based follow up in people with Sleep Apnea Syndromes, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
Obstructive sleep apnea (OSA) is treated with a continuous positive airway pressure, so called CPAP. A new technology that enables telemetric monitoring of CPAP therapy. This study randomizes 560 patients to A) conventional follow up procedures or B to a telemedicine based follow up procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea Syndromes
- What is being tested?
- CPAP, conventional follow up and CPAP, telemedicine based follow up
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 403 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2018to 23 Dec 2019
- 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
- Verified sleep apnea diagnosis according to ICSD II criteria
- Indication for CPAP treatment according to Swedish national guidelines
- Capacity to read and understand the Swedish language
- Willingness to test CPAP treatment
Who cannot join
- Instable concomitant disease requiring frequent hospitalization
- Alcohol and drug abuse
- Non-availability during the follow up during 3 months (e.g. frequent or long-term travelling)
- Hypoventilation syndrome with PCO2>7kpa
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Sahlgrenska University Hospital, Sleep Disorders Center
Gothenburg, 41345
About this study
Official title: Cloud Based Follow up of CPAP Treatment in Sleep Apnea Patients - a Multi Center Randomized Controlled Trial
Obstructive sleep apnea (OSA) is treated with a continuous positive airway pressure, so called CPAP. A new technology that enables telemetric monitoring of CPAP therapy. This study randomizes 560 patients to A) conventional follow up procedures or B to a telemedicine based follow up procedure. Main endpoint parameter is CPAP treatment compliance at 3 months after start of treatment.
Read the detailed description
Background:
Obstructive sleep apnea (OSA) is treated with a continuous positive airway pressure, so called CPAP, during sleep. CPAP startup and follow-up is performed at four sleep clinics in the West Swedish Region (SU / S, SÄS, SkaS, NÄL). Patient volumes are high, waiting times are long and long-term follow-up is inconsistent. A new technology that enables telemetric monitoring of CPAP therapy based on transfer of therapy data to a data cloud has been introduced. Healthcare personnel can identify patients with therapy problems.
Data from minor studies suggest several benefits of this telemedicine solution (increased therapeutic capacity, lower patient and community costs and a time benefit for the sleep medicine unit). Today, the sleep Clinical in the region use different procedures for monitoring CPAP treatment.
Scientific question:
Is telemedicine monitoring of CPAP treatment an adequate solution for follow up in all patients ? Is the additional cost of a telemedicine solution balanced by a better outcome after therapy?
Hypothesis:
Intensive telemedicine monitoring, especially at the start of CPAP therapy, leads to improved CPAP care at the participating sleep units.
Method:
The study randomizes 560 patients (moderate to severe sleep apnea) to different CPAP treatment follow up procedures: A) the current routine of the sleep clinic or B) the new telemedicine solution (1: 1 randomization). The main outcome parameter of the study is the mean CPAP use after 3 months of treatment. Secondary outcome parameters include the reduction of sleep apnea intensity, daytime sleepiness, and patient-related outcome measures (PROM).
Aim:
The aim of the study is to map the pros and cons of a telemedicine solution in CPAP therapy regarding treatment outcomes, patient quality of life and resource utilization at the sleep center.
- Conditions
- Sleep Apnea Syndromes
- Being tested
- CPAP, conventional follow up, CPAP, telemedicine based follow up
- Keywords
- Compliance, Telemedicine, Patient related outcome measures
- Medical subject headings
- Sleep Apnea Syndromes, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP, conventional follow upDevice
Positive airway pressure to splint the airway and to prevent apneas during sleep. Follow up of patients after initiation of treatment according to clinical routine at the study site. Patients are informed to call or visit the sleep center in case of problems with the CPAP device. At 3 months a follow up visit is scheduled at the sleep center. CPAP compliance data will be downloaded and all patients fill in a number of questionaires related to the CPAP treatment effects on sleep apnea symptoms and health related quality of Life. Mask fitting will be tested.
CPAP, telemedicine based follow upDevice
Follow up of patients by means of a telemedicine solution for surveillance of CPAP treatment, Compliance with and efficacy of CPAP can be followed up by the sleep center personnel on a regular basis. Patients with low compliance and mask fitting problems will be contacted by phone. At the end of the 3 months period a visit at the sleep center will be scheduled only for patients with low compliance, low treatment efficacy, or high mask leakage. All patients will be asked to fill in a number of questionaires related to CPAP treatment effects on sleep apnea symptoms and health related quality of Life.
| Study group | Role | What they receive |
|---|---|---|
| CPAP, conventional follow up | Active comparator | Follow up of patients after initiation of treatment according to clinical routine at the study site. Receives: Device: CPAP, conventional follow up |
| CPAP, telemedicine based follow up | Active comparator | Follow up of patients after initiation of treatment according to a telemedicine based routine. Receives: Device: CPAP, telemedicine based follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPAP treatment compliance at 3 months
Mean nightly use of CPAP treatment (h/night) according to the built in time counter of the CPAP device, between group difference
Measured: 3 months
Secondary outcomes (5)
Reduction of daytime sleepiness
Reduction of the score in the Epworth Sleepiness Scale Score (range 0-24, 0=no sleepiness, 24=very high sleepiness, summary score from 8 different questions about the probability of daytime sleepiness, each question can generate between 0=unlikely and 4=highly likely points), assessment at baseline and at follow up, between group difference
Measured: 3 months
Reduction of the degree of sleep apnea
Between Group difference in the reduction of the Apnea Hypopnea Index (n/h) from baseline (no treatment) to follow up (with CPAP on)
Measured: 3 months
Non Acceptance Rate of CPAP therapy
Proportion of patients refusing CPAP therapy, between group difference
Measured: 3 months
Health care utilization during follow up
Time spent for follow up procedures by the Health care personel, between group difference
Measured: 3 months
Patient satisfaction regarding the follow up procedure
Visual Analogue Scale (VAS) Rating of patient satisfaction with the two different follow up procedures, VAS scale has 0 to 100 Points where 0=very low satisfaction and 100= very high satisfaction, no subscales.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start1 Jan 2018
- Primary completion30 Apr 2019
- Study completion23 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea SyndromesStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, open-label, multicenter, parallell group design
- Masking
- None (open label)
- Enrolment
- 403 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Collaborators
- Borås Lasarett, Skaraborgs Hospital, NU-Hospital Organization, Sweden
- Responsible party
- Principal investigator, Ludger Grote, Vastra Gotaland Region
- Investigators
- Ludger Grote, Principal investigator, Respiratory Medicine, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03446560
- Sponsor's protocol ID
- VGFOUREG-663941
- Other IDs
- 227161
- Status last verified
- Jan 2020
- First submitted
- 18 Jan 2018
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fridriksson B, Berndtson M, Hamnered H, Faeder E, Zou D, Hedner J, Grote L. Beneficial Effects of Early Intervention Telemedicine-based Follow-Up in Sleep Apnea: A Randomized Controlled Multicenter Trial. Ann Am Thorac Soc. 2023 Oct;20(10):1499-1507. doi: 10.1513/AnnalsATS.202208-723OC.
PubMed 37463309
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cloud Based Follow up of CPAP Treatment in Sleep Apnea Patients - a Multi Center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03446560
- Acronym / sponsor ID
- VGFOUREG-663941
- Conditions
- Sleep Apnea Syndromes
- Keywords
- Compliance, Telemedicine, Patient related outcome measures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 403 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Collaborators
- Borås Lasarett, Skaraborgs Hospital, NU-Hospital Organization, Sweden
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 23 Dec 2019 (actual)
- First posted
- 27 Feb 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.
Obstructive sleep apnea (OSA) is treated with a continuous positive airway pressure, so called CPAP. A new technology that enables telemetric monitoring of CPAP therapy. This study randomizes 560 patients to A) conventional follow up procedures or B to a telemedicine based follow up procedure. Main endpoint parameter is CPAP treatment compliance at 3 months after start of treatment.
Detailed description
Background:
Obstructive sleep apnea (OSA) is treated with a continuous positive airway pressure, so called CPAP, during sleep. CPAP startup and follow-up is performed at four sleep clinics in the West Swedish Region (SU / S, SÄS, SkaS, NÄL). Patient volumes are high, waiting times are long and long-term follow-up is inconsistent. A new technology that enables telemetric monitoring of CPAP therapy based on transfer of therapy data to a data cloud has been introduced. Healthcare personnel can identify patients with therapy problems.
Data from minor studies suggest several benefits of this telemedicine solution (increased therapeutic capacity, lower patient and community costs and a time benefit for the sleep medicine unit). Today, the sleep Clinical in the region use different procedures for monitoring CPAP treatment.
Scientific question:
Is telemedicine monitoring of CPAP treatment an adequate solution for follow up in all patients ? Is the additional cost of a telemedicine solution balanced by a better outcome after therapy?
Hypothesis:
Intensive telemedicine monitoring, especially at the start of CPAP therapy, leads to improved CPAP care at the participating sleep units.
Method:
The study randomizes 560 patients (moderate to severe sleep apnea) to different CPAP treatment follow up procedures: A) the current routine of the sleep clinic or B) the new telemedicine solution (1: 1 randomization). The main outcome parameter of the study is the mean CPAP use after 3 months of treatment. Secondary outcome parameters include the reduction of sleep apnea intensity, daytime sleepiness, and patient-related outcome measures (PROM).
Aim:
The aim of the study is to map the pros and cons of a telemedicine solution in CPAP therapy regarding treatment outcomes, patient quality of life and resource utilization at the sleep center.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, open-label, multicenter, parallell group design
| Arm | Type | Receives |
|---|---|---|
| CPAP, conventional follow up | Active comparator | Device: CPAP, conventional follow upFollow up of patients after initiation of treatment according to clinical routine at the study site. |
| CPAP, telemedicine based follow up | Active comparator | Device: CPAP, telemedicine based follow upFollow up of patients after initiation of treatment according to a telemedicine based routine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Verified sleep apnea diagnosis according to ICSD II criteria
- Indication for CPAP treatment according to Swedish national guidelines
- Capacity to read and understand the Swedish language
- Willingness to test CPAP treatment
Key exclusion criteria (4 listed)
- Instable concomitant disease requiring frequent hospitalization
- Alcohol and drug abuse
- Non-availability during the follow up during 3 months (e.g. frequent or long-term travelling)
- Hypoventilation syndrome with PCO2>7kpa
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 |
|---|---|---|
| CPAP, conventional follow upPositive airway pressure to splint the airway and to prevent apneas during sleep. Follow up of patients after initiation of treatment according to clinical routine at the study site. Patients are informed to call or visit the sleep center in case of problems with the CPAP device. At 3 months a follow up visit is scheduled at the sleep center. CPAP compliance data will be downloaded and all patients fill in a number of questionaires related to the CPAP treatment effects on sleep apnea symptoms and health related quality of Life. Mask fitting will be tested. | Device | CPAP, conventional follow up |
| CPAP, telemedicine based follow upFollow up of patients by means of a telemedicine solution for surveillance of CPAP treatment, Compliance with and efficacy of CPAP can be followed up by the sleep center personnel on a regular basis. Patients with low compliance and mask fitting problems will be contacted by phone. At the end of the 3 months period a visit at the sleep center will be scheduled only for patients with low compliance, low treatment efficacy, or high mask leakage. All patients will be asked to fill in a number of questionaires related to CPAP treatment effects on sleep apnea symptoms and health related quality of Life. | Device | CPAP, telemedicine based follow up |
Primary outcome
CPAP treatment compliance at 3 months
Time frame: 3 months
Mean nightly use of CPAP treatment (h/night) according to the built in time counter of the CPAP device, between group difference
5 secondary outcomes
Reduction of daytime sleepiness
Time frame: 3 months
Reduction of the degree of sleep apnea
Time frame: 3 months
Non Acceptance Rate of CPAP therapy
Time frame: 3 months
Health care utilization during follow up
Time frame: 3 months
Patient satisfaction regarding the follow up procedure
Time frame: 3 months
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 14 Jan 2020.
- Derived from this study: PubMed 37463309Fridriksson B, Berndtson M, Hamnered H, Faeder E, Zou D, Hedner J, Grote L. Beneficial Effects of Early Intervention Telemedicine-based Follow-Up in Sleep Apnea: A Randomized Controlled Multicenter Trial. Ann Am Thorac Soc. 2023 Oct;20(10):1499-1507. doi: 10.1513/AnnalsATS.202208-723OC.
- Individual participant dataSharing planned: No
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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.
Ludger Grote principal investigator
Respiratory Medicine, Sahlgrenska University Hospital
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, conventional follow up and CPAP, telemedicine based follow up in people with Sleep Apnea Syndromes, run by Vastra Gotaland Region at 1 site in Sweden.
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 4 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: finished, as of the sponsor's last update on 14 Jan 2020. 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 Sweden. 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?
CPAP treatment compliance at 3 months (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03446560, which also lists 1 linked publication.
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 14 Jan 2020; AzTrials last refreshed its copy on 1 Nov 2026.