An interventional study of CPAP, conventional follow up and CPAP, telemedicine based follow up in Sleep Apnea Syndromes, sponsored by Vastra Gotaland Region. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-14.
Sponsored by Vastra Gotaland Region · Not applicable, Interventional, and Treatment
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Among 16 studies in Sleep Apnea Syndromes with a site in Sweden — 3 open to participants now, 4 under way, none of them phase 3. Sleep Apnea Syndromes · Sweden.
Among the 16 studies in Sleep Apnea Syndromes with a site in Sweden, this one is the 3rd largest by enrollment of the 12 interventional ones that give a count, is the only one that started in 2018, is one of 8 with no phase, and was the 13th registered.
1,084 studies on the registry are indexed under Sleep Apnea Syndromes; 171 are open to participants now.
Browse Sleep Apnea Syndromes studies →3 of the 16 studies in Sleep Apnea Syndromes with a site in Sweden are open now. Recruiting first, the newest first:
Malin Eleonora av Kák Gustafsson, MD, PhD · Sites in Sweden
Ages 18+
Jani Talvilahti · Sites in Sweden
Ages 18–70
Blekinge County Council Hospital · Sites in Sweden
Ages 18+
A study can be open while its sites in Sweden have not opened yet or have stopped. Only those recruiting at a site in Sweden →
Of the 117 Sleep Apnea Syndromes studies recruiting now, 57 (49%) set no upper age limit and 36 (31%) stop at 75 or younger; 24 take children under 18; 27 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
16 studies; the count open now beside each. This study's row is marked.
First in 1993; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 403 is above the median of 60 across 673 interventional studies indexed under Sleep Apnea Syndromes.
Median enrollment 93 across the 12 interventional studies, 283 across the 4 observational. Of the 12 that completed or were terminated, 3 (25%) have results posted.
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3 of 16 have an industry lead sponsor. The 10 most frequent:
Vastra Gotaland Region is the lead sponsor of 276 studies on the registry; 110 are open to participants now.
Vastra Gotaland Region has 1 study filed under Sleep Apnea Syndromes — fewer than ten, so there is no comparison to draw.
1 of the studies in Sleep Apnea Syndromes with a site in Sweden that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06811948Blekinge County Council HospitalSleep-Disordered Breathing in the Acute Phase After Stroke and Neuropsychiatric Outcomes | 2027-05-20 |
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Among the 16 studies in Sleep Apnea Syndromes with a site in Sweden, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Follow up of patients after initiation of treatment according to clinical routine at the study site.
Device: CPAP, conventional follow up
Follow up of patients after initiation of treatment according to a telemedicine based routine.
Device: CPAP, telemedicine based follow up
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.
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.
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
Time frame: 3 months
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
Time frame: 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)
Time frame: 3 months
Non Acceptance Rate of CPAP therapy
Proportion of patients refusing CPAP therapy, between group difference
Time frame: 3 months
Health care utilization during follow up
Time spent for follow up procedures by the Health care personel, between group difference
Time frame: 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.
Time frame: 3 months
Degree of comorbid depression and anxiety symptoms
Score of the Hospital Anxiety and Depression Scale (HADS) pre and post treatment, between group differences. The HADS scale consists of 7 questions for anxiety rating (each question can generate 0-1 Point), the points from each question will be summarized to a total score with has a range of 0-21 (0=no anxiety and 21=severe anxiety). The depression rating is performed according to the same principle (seven questions, summary score with a range 0 to 21).
Time frame: 3 months
Degree of comorbid insomnia
Score of the Insomnia Severity Index (ISI) Score pre and post treatment, between group differences. The questionnaire consists of 7 questions, each generating 0 (no insomnia problem) or up to 4 (very severe insomnia problems) Points. The 7 questions can generate a summary score between 0 and 28.
Time frame: 3 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2018 to primary completion in Apr 2019, 15 months.
Of 200 non-industry interventional studies with no phase under Sleep Apnea Syndromes, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 60. This study's 15 months is below that.
Counting every sponsor, half of 268 studies reached it within 26 months; a quarter within 11 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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