Home Sleep Testing in Neuromuscular Disease Patients (HSTNMD)

This study has suspended participant recruitment.
(Ambulatory monitor company bankrupt)
Sponsor:
Information provided by:
Landon Pediatric Foundation
ClinicalTrials.gov Identifier:
NCT00695591
First received: June 3, 2008
Last updated: June 21, 2011
Last verified: June 2011
  Purpose

Lay Summary Patients with severe neuromuscular develop hypoventilation, which leads to elevated carbon dioxide levels. Measuring only oxygen saturation levels with pulse oximetry may be inadequate. End tidal carbon dioxide levels or arterial blood gases should be measured periodically, depending on the clinical condition of the patient. A thorough review of systems will help define any problems. Patients who are hypoventilating often have elevated carbon dioxide levels at night and complain of a morning headache, restlessness or nightmares, and poor quality sleep. This may cause daytime sleepiness. Insufficient respiration with hypoxia may occur later, especially if the lung is damaged by chronic aspiration.

We propose to evaluate the use of the Nonin LifeSense monitor in home evaluation of respiration, oxygen level, heart rate, and carbon dioxide level and to develop interpretation of the results that will lead to appropriate interventions for apnea, and insufficient respiration.

Relevance to MDA Fewer than one per cent of the Muscular Dystrophy Association have pulmonologists as co-directors.Late referral of progressive restrictive lung disease leads to invasive support of respiratory failure. Early initiation of non invasive ventilation techniques requires patience on the part of the caregiver and exploration of mask interfaces and ventilation techniques. In addition, the development of new therapies, currently manifested through enhanced diagnostic accuracy, will require new signal for initiation and in the assessment of success or failure.

Aims Aim 1. To assess the utility of a small portable device (LifeSense Monitor Nonin Medical Inc. Plymouth Minnesota) with extended recording capabilty to provide accurate diagnosis of hypoventilation.

Aim 2. To provide an easily interpretable report defining sleep hypoxemia, hypercapnea, and apnea.

Aim 3. To promote early evaluation and treatment of the respiratory problems in centers that do not have pumonologists as these are essential to prognosis, whether of survival or of quality of life, in neuromuscular diseases.


Condition Intervention
Neuromuscular Disease
Other: Evaluation for Nocturnal non invasive ventilation

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Home Sleep Testing in Neuromuscular Disease Patients

Resource links provided by NLM:


Further study details as provided by Landon Pediatric Foundation:

Primary Outcome Measures:
  • 1. End tidal CO2 catheter is tolerated for six hours or more [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 1. Interpretable data are captured for oximetry, heart rate, and end-tidal CO2 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • 2. An interpretive report is generated that will guide the non-pulmonary physician in potential interventions [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • 2. Patients and parents are able to apply the monitors at home and a six hour data set is collected [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: July 2008
Estimated Study Completion Date: July 2012
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1SevereRLD,NMD
Patients with FEV1<40%
Other: Evaluation for Nocturnal non invasive ventilation
Patients will be referred for evaluation for NNIV is indicated in patients with diurnal Pa,CO2 >6.0 Pa; and 2) nocturnal Sa,O2 <88% for 5 consecutive min. End tidal CO2 representing equivalent values will be referred for NNIV
2VerySevereRLD,NMD
FEV1<30%
Other: Evaluation for Nocturnal non invasive ventilation
Patients will be referred for evaluation for NNIV is indicated in patients with diurnal Pa,CO2 >6.0 Pa; and 2) nocturnal Sa,O2 <88% for 5 consecutive min. End tidal CO2 representing equivalent values will be referred for NNIV
3NINV
FEV1<25%,on non invasive ventilation
Other: Evaluation for Nocturnal non invasive ventilation
Patients will be referred for evaluation for NNIV is indicated in patients with diurnal Pa,CO2 >6.0 Pa; and 2) nocturnal Sa,O2 <88% for 5 consecutive min. End tidal CO2 representing equivalent values will be referred for NNIV
ModerateRLD,NMD
Patients with FEV1 40-50% of predicted
Other: Evaluation for Nocturnal non invasive ventilation
Patients will be referred for evaluation for NNIV is indicated in patients with diurnal Pa,CO2 >6.0 Pa; and 2) nocturnal Sa,O2 <88% for 5 consecutive min. End tidal CO2 representing equivalent values will be referred for NNIV

  Eligibility

Ages Eligible for Study:   8 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Study Population Description Patients from the Neuromuscular Disease Clinic at Ventura County Medical Center

Non-Probability Sample: invitation to volunteer

Neuromuscular Disease

Criteria

Inclusion Criteria:

  • Clinical diagnosis of neuromuscular disease
  • Must have home caregivers

Exclusion Criteria:

  • No home caregiver
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00695591

Locations
United States, California
Pediatric Diagnostic Center
Ventura, California, United States, 93003
Sponsors and Collaborators
Landon Pediatric Foundation
Investigators
Principal Investigator: Chris Landon, MD Landon Pediatric Foundation
  More Information

Additional Information:
Publications:
Responsible Party: Chris Landon MD
ClinicalTrials.gov Identifier: NCT00695591     History of Changes
Other Study ID Numbers: LS01
Study First Received: June 3, 2008
Last Updated: June 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Landon Pediatric Foundation:
Home sleep testing neuromuscular disease
Neuromuscular disease patients with FEV1<50% of predicted

Additional relevant MeSH terms:
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 24, 2014