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

NCT03506906 | Completed

• 1 other identifier: WI_18-023
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypoventilation Syndrome; Chronic Obstructive Pulmonary Disease; Obesity Hypoventilation Syndrome; Restrictive Lung Disease; Neuromuscular Diseases

Keywords

Chronic hypoventilation syndrome; Polysomnography; Transcutaneous Capnometry; Noninvasive Ventilation; home mechanical ventilation; Ventilator´s set-up

Outcome Measures

Primary Outcomes (1)

• Adjustment of non-invasive ventilation

  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): 1. Non-invasive ventilation therapy optimization is not required (all ventilator's parameters should stay unchanged) 2. Optimization of non-invasive ventilation therapy is required (one or more of the ventilator's parameters should be re-set, irrespective of the magnitude)

  One day

Secondary Outcomes (3)

• Non-invasive ventilation compliance

  6 months

• Health-related quality of life: questionnaire

  6 months

• arterial level of carbon dioxide

  6 months

Study Arms (2)

Conventional-approach

ACTIVE COMPARATOR

The non-invasive ventilation therapy will be optimized according to routine tests (blood gas analysis, lung function, ventilator's built-in software analysis)

Diagnostic Test: Routine tests

Sleep studies-based approach

EXPERIMENTAL

Additionally to the routine tests, the results of a nocturnal polysomnography and transcutaneous capnometry under the non-invasive ventilation therapy will be considered for the therapy optimization.

Diagnostic Test: Sleep studies under noninvasive ventilation therapy; Diagnostic Test: Routine tests

Interventions

Sleep studies under noninvasive ventilation therapy DIAGNOSTIC_TEST

Polysomnography Transcutaneous capnography

Sleep studies-based approach

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)

Conventional-approach; Sleep studies-based approach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wissenschaftliches Institut Bethanien e.V: lead

Study Sites (1)

Krankenhaus Bethanien

Solingen, North Rhine-Westphalia, 42699, Germany

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Obesity Hypoventilation Syndrome; Neuromuscular Diseases

Interventions

Diagnostic Tests, Routine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Winfried J Randerath, Prof. Dr.

  Krankenhaus Bethanien

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2018
• First Posted: April 24, 2018
• Study Start: November 11, 2018
• Primary Completion: September 25, 2019
• Study Completion: September 21, 2020
• Last Updated: October 7, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)