Respiratory Monitoring of Intrathecal Baclofen- a Feasibi... | NCT03151941

Studies
Respiratory Monitoring of Intrathecal Baclofen- a Feasibility Study

NCT03151941

Sponsor

Solent NHS Trust

Status

Completed

Last Update Posted

Oct 10, 2017Actual

Enrollment

15Actual

Phase

Not provided

Conditions

Intrathecal Baclofen
Multiple Sclerosis
Respiratory System
Cerebral Palsy

Interventions

Not provided

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 6, 2017Actual

Primary Completion Date

Aug 31, 2017Actual

Completion Date

Aug 31, 2017Actual

First Submitted Date

Mar 13, 2017

First Submission Date that Met QC Criteria

May 10, 2017

First Posted Date

May 12, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 9, 2017

Last Update Posted Date

Oct 10, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The methodology is a feasibility study to determine the feasibility of assessing people in the community with a neurological condition before proceeding towards a full powered community trial evaluating the influence of intrathecal baclofen.

Detailed Description

The purpose of this proposed research will evaluate a feasible method to assess the respiratory status of people with neurological conditions receiving or scheduled to receive Intrathecal Baclofen. The use of Intrathecal Baclofen to manage severe spasticity is a developing treatment option with a limited research base, particularly when evaluating the influence of intrathecal baclofen on the respiratory system. The proposed research is derived from clinical practice and involves joint collaboration between clinical team, research professionals and patients.

In order for the study to evaluate the influence of Intrathecal baclofen has on the respiratory system, the proposed research will need to develop and evaluate a method of assessing people in the community ensuring it's feasible for people with neurological conditions. Prior to implementing a full powered community trial to evaluate the influence of intrathecal baclofen on people with neurological conditions.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overnight home polysomnography	sleep study	2 nights

Secondary Outcomes

Measure	Description	Time Frame
Sniff nasal inspiratory pressure Expiratory and inspiratory mouth pressures Cough peak flow Expanded disability status scale Epworth sleepiness scale Semi Structured interview	Sniff nasal inspiratory pressure Expiratory and inspiratory mouth pressures Cough peak flow Expanded disability status scale Epworth sleepiness scale Semi Structured interview	2 nights

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

-Adults over the age of 18
A person who is able to provide consent or a family member/ close friend who is able to assent on behalf of the participant
A person or a family member/ close friend who is able to understand English (understand written English and spoken instructions)
A person currently receiving Intrathecal Baclofen or is scheduled to receive Intrathecal Baclofen (awaiting fitting of pump) therapy to manage spasticity
A patient of the Solent/ University Hospitals Southampton NHS Foundation Trust Intrathecal baclofen service

Exclusion Criteria:

-Pre-existing use of overnight non-invasive ventilation (NIV) and is compliant with NIV treatment
A person who is unable to consent to the study and does not have a family/ close person to assent
The study will exclude a person who is unable to independently remove the polysomnography and is also without supervision from another person (carer or partner) during the night. This ensures the participant is able to take off the polysomnography (or assisted by a carer) if it becomes uncomfortable and/or causes distress.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

110 Years

Standard Ages

AdultOlder Adult

Study Population

People with Neurological conditions receiving or scheduled to receive intrathecal baclofen therapy.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Hayden Kirk	Solent NHS Trust	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Solent NHS Trust		Portsmouth	Hampshire		United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009103	Multiple Sclerosis
D002547	Cerebral Palsy

Ancestor Terms

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases

Browse Leaves

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Browse Branches

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