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NCT00695591 · ClinicalTrials.gov registry record

Home Sleep Testing in Neuromuscular Disease Patients

A clinical trial of Neuromuscular Disease, sponsored by Landon Pediatric Foundation.

Completed
Registry status
9
Enrollment target
1
Study location

NCT00695591 is a study of Neuromuscular Disease that has completed, run by Landon Pediatric Foundation. The registered enrollment target is 9 participants, below the 279-participant average among 6 other Neuromuscular Disease trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00695591, a study of Neuromuscular Disease, has completed, sponsored by Landon Pediatric Foundation.

COMPLETED
Registry status
9 participants
Enrollment target
1
Study location

Study Summary

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

Conditions Studied

Interventions

  • OTHER Evaluation for Nocturnal non invasive ventilation

Study Locations (1)

California

  • Pediatric Diagnostic Center - Ventura

Trial Details

FieldValue
Enrollment Target 9 participants
Start Date 2008-07
Est. Completion 2009-07

Sponsor

Landon Pediatric Foundation

11 total trials

What the Registry Record Tells You About NCT00695591

The ClinicalTrials.gov registry entry for NCT00695591 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 279-participant average among 6 other Neuromuscular Disease trials with a reported enrollment target (97% lower). The listed sponsor is Landon Pediatric Foundation, which has 11 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Neuromuscular Disease appearing as the primary indexed condition, and to 1 intervention - of which Evaluation for Nocturnal non invasive ventilation is the first listed.

NCT00695591 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT00695591 about?

NCT00695591 is a clinical study titled "Home Sleep Testing in Neuromuscular Disease Patients". 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 ...

What is the current status of trial NCT00695591?

This trial is currently completed. The enrollment target is 9 participants. The study started on 2008-07. Estimated completion is 2009-07.

What conditions does trial NCT00695591 study?

This clinical trial studies the following conditions: Neuromuscular Disease.

What interventions are being tested in trial NCT00695591?

The interventions under investigation include: Evaluation for Nocturnal non invasive ventilation (OTHER).

Who is sponsoring clinical trial NCT00695591?

This trial is sponsored by Landon Pediatric Foundation, which has 11 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00695591 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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