Home Sleep Testing in Neuromuscular Disease Patients

Neuromuscular Disease Clinical Trial

— HSTNMD  

Official title:

Home Sleep Testing in Neuromuscular Disease Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00695591
• Other study ID #: LS01
• Status: Completed
• Phase: N/A
• First received: June 3, 2008
• Last updated: August 12, 2014
• Start date: July 2008
• Est. completion date: July 2009

Study information

• Verified date: August 2014
• Source: Landon Pediatric Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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 these are essential to prognosis, whether of survival or of quality of life, in neuromuscular diseases.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: July 2009
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 50 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of neuromuscular disease

• Must have home caregivers

Exclusion Criteria:

• No home caregiver

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Neuromuscular Disease
• Neuromuscular Diseases

Intervention

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

Locations

Country	Name	City	State
United States	Pediatric Diagnostic Center	Ventura	California

Sponsors (1)

Lead Sponsor	Collaborator
Landon Pediatric Foundation

Country where clinical trial is conducted

United States, 

References & Publications (4)

Birnkrant DJ, Panitch HB, Benditt JO, Boitano LJ, Carter ER, Cwik VA, Finder JD, Iannaccone ST, Jacobson LE, Kohn GL, Motoyama EK, Moxley RT, Schroth MK, Sharma GD, Sussman MD. American College of Chest Physicians consensus statement on the respiratory and related management of patients with Duchenne muscular dystrophy undergoing anesthesia or sedation. Chest. 2007 Dec;132(6):1977-86. — View Citation

Kirk VG, Flemons WW, Adams C, Rimmer KP, Montgomery MD. Sleep-disordered breathing in Duchenne muscular dystrophy: a preliminary study of the role of portable monitoring. Pediatr Pulmonol. 2000 Feb;29(2):135-40. — View Citation

Kumar SP, Sword D, Petty RK, Banham SW, Patel KR. Assessment of sleep studies in myotonic dystrophy. Chron Respir Dis. 2007;4(1):15-8. — View Citation

Shneerson JM, Simonds AK. Noninvasive ventilation for chest wall and neuromuscular disorders. Eur Respir J. 2002 Aug;20(2):480-7. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1. End tidal CO2 catheter is tolerated for six hours or more		3 months	No
Secondary	1. Interpretable data are captured for oximetry, heart rate, and end-tidal CO2		3 months	No
Secondary	2. An interpretive report is generated that will guide the non-pulmonary physician in potential interventions		6 months	No
Secondary	2. Patients and parents are able to apply the monitors at home and a six hour data set is collected		3 months	No

External Links

•   Novel Methods of Ambulatory Physiologic Monitoring in Patients With Neuromuscular Disease