NCT00415727

Brief Summary

The hypothesis is that in sickle cell anaemia, nocturnal oxyhaemoglobin desaturation, is associated with low processing speed index, and this morbidity can be reduced with overnight auto Continuous Positive Airways Pressure and/or oxygen supplementation.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 25, 2006

Completed
Last Updated

December 25, 2006

Status Verified

December 1, 2006

First QC Date

December 22, 2006

Last Update Submit

December 23, 2006

Conditions

Sickle Cell Anaemia

Outcome Measures

Primary Outcomes (1)

  • Change in processing speed index

Secondary Outcomes (7)

  • Frequency of pain measured via SMS and pain diary

  • Adverse events e.g. headache, anorexia, weight loss, nausea, vomiting, reduction in steady state red or white cell count

  • Change in Blood pressure

  • Number of omissions on Conners Continuous Performance Test

  • Change in Chervin sleep Questionnaire

  • +2 more secondary outcomes

Interventions

auto Continuous Positive Airways Pressure (CPAP) with oxygen supplementationDEVICE

Eligibility Criteria

Age4 Years - 16 Years
Sexall
Age GroupsChild (0-17)

You may qualify if:

  • Age \>4 years.
  • Informed consent with assent in accordance with UK ethical committee(COREC) system must be signed by the patient's parent or legally authorized guardian acknowledging written consent to join the study. When suitable, patients will be requested to give their assent to join the study.
  • Haemoglobin SS (homozygous sickle cell anaemia) diagnosed by standard techniques. Participating institutions must submit documentation of the diagnostic haemoglobin analysis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Neuroscience Unit, Institute of Child Health

London, WC1N 1EH, United Kingdom

RECRUITING

Kings College hospital

London, WC2R 2LS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Fenella Kirkham, Dr

    Institute Of Child Health and Great Ormond Street Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fenella Kirkham, Dr

CONTACT

f.kirkham@ich.ucl.ac.uk

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 22, 2006

First Posted

December 25, 2006

Study Start

November 1, 2006

Last Updated

December 25, 2006

Record last verified: 2006-12

Locations

GB(2)