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NCT Number: NCT03506906

The Debated Role of Sleep Studies in Patients Under Established Home Mechanical Ventilation

Patients suffering chronic hypercapnic respiratory insufficiency (e.g. in chronic obstructive pulmonary disease, obesity hypoventilation syndrome) benefit from home mechanical ventilation. These patients are complex; and the ventilator´s parameters should be set-up according to the underlying disease and particular patient's characteristics. The non-invasive ventilation therapy is mostly titrated while the patient is awake, hence Problems, such as Patient-Ventilator asynchrony, arising while sleeping on the ventilator therapy would remain undetected.

Sleep studies, such as polysomnography or polygraphy and transcutaneous carbon dioxide monitoring could be valuable tools to fine-tune the ventilator's settings. This could foster the ventilator´s effectivity and patient satisfaction, thus therapy's adherence. Nevertheless the sleep studies are expensive, time-consuming and not widely available.

The aim of this study is to learn the findings of sleep studies when they are performed on stable patients on home mechanical ventilation as part of their routine check-ups. In this context, it will be assessed whether the sleep studies' findings lead to a change (adjustment) of the ventilator´s therapy. Moreover, this study aims to investigate whether the absence of sleep studies would result in missing important events that require an adjustment of therapy. The results of this study could provide information that lead to a more standardized protocol of follow-up checks of patients on home mechanical ventilation in a cost-effective manner.

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Key information

Conditions

Hypoventilation Syndrome Apnea Chronic Disease Chronic Obstructive Pulmonary Disease Disease Attributes Dyssomnias Hypoventilation Lung Diseases Lung Diseases, Obstructive Nervous System Diseases Neuromuscular Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity Hypoventilation Syndrome Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Restrictive Lung Disease Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Krankenhaus Bethanien

Solingen, North Rhine-Westphalia, 42699, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with chronic hypercapnic respiratory failure secondary to one or more identified condition(s) (chronic obstructive pulmonary disease, obesity hypoventilation syndrome, neuromuscular diseases, restrictive lung diseases)
  • Home mechanical ventilation for ≥ 6 months
  • Stable condition for ≥ 1 month

Exclusion criteria

  • Previous adjustment of the noninvasive ventilation therapy under sleep studies in the last 6 months
  • Current respiratory exacerbation
  • Any current comorbidity decompensation
  • Any medical or psychological condition impairing the patient's ability to provide informed consent
  • Missing signed informed consent
  • Total sleep time during polysomnography <180 min

Treatment and study plan

Sleep studies under noninvasive ventilation therapy

Diagnostic Test

Polysomnography Transcutaneous capnography

Routine tests

Diagnostic Test

Spirometry, six minute walk test, blood gas analysis, questionnaires (Epworth sleepiness score, health related quality of life severe respiratory insufficiency questionnaire)

Primary outcomes

  1. Adjustment of non-invasive ventilation

    Time frame: One day

    Each case will be evaluated separately by 2 investigators. One of them will be provided with the diurnal evaluations only (as routinely); the second investigator will additionally have access to the sleep studies. Each investigator will classify the case as one of the following labels (primary outcome):

    • Non-invasive ventilation therapy optimization is not required (all ventilator's parameters should stay unchanged)
    • Optimization of non-invasive ventilation therapy is required (one or more of the ventilator's parameters should be re-set, irrespective of the magnitude)

Secondary outcomes

  1. Non-invasive ventilation compliance

    Time frame: 6 months

    The ventilator's optimization will be performed randomly according to the clinical-based approach or the sleep studies-based approach. In the next follow-up visit, both arms will be re-evaluated. The change in non-invasive ventilation therapy compliance will be explored based on the ventilator´s built-in software data.

  2. Health-related quality of life: questionnaire

    Time frame: 6 months

    In the next follow-up visit, the health-related quality of life of both groups will be evaluated with the severe respiratory insufficiency questionnaire.

  3. arterial level of carbon dioxide

    Time frame: 6 months

    In the next follow-up visit, the arterial level of carbon dioxide of both groups will be evaluated in the blood gas analysis

Sponsors and collaborators

Lead sponsor

Wissenschaftliches Institut Bethanien e.V

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Apr 24, 2018
Registry last updated
Oct 7, 2021

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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