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NCT Number: NCT03446560

Cloud Based Follow up of CPAP Treatment

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.

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Key information

Conditions

Sleep Apnea Syndromes Apnea Behavior Dyssomnias Health Behavior Nervous System Diseases Patient Acceptance of Health Care Patient Compliance Respiration Disorders Respiratory Tract Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska University Hospital, Sleep Disorders Center

Gothenburg, 41345, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

CPAP, conventional follow up

Device

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 up

Device

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Reduction of daytime sleepiness

    Time frame: 3 months

    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

  2. Reduction of the degree of sleep apnea

    Time frame: 3 months

    Between Group difference in the reduction of the Apnea Hypopnea Index (n/h) from baseline (no treatment) to follow up (with CPAP on)

  3. Non Acceptance Rate of CPAP therapy

    Time frame: 3 months

    Proportion of patients refusing CPAP therapy, between group difference

  4. Health care utilization during follow up

    Time frame: 3 months

    Time spent for follow up procedures by the Health care personel, between group difference

  5. Patient satisfaction regarding the follow up procedure

    Time frame: 3 months

    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.

Other outcomes

  1. Degree of comorbid depression and anxiety symptoms

    Time frame: 3 months

    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).

  2. Degree of comorbid insomnia

    Time frame: 3 months

    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.

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Collaborators

  • Borås Lasarett
  • NU-Hospital Organization, Sweden
  • Skaraborgs Hospital

Registry information

Official study title

Cloud Based Follow up of CPAP Treatment in Sleep Apnea Patients - a Multi Center Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 27, 2018
Registry last updated
Jan 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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