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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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5 June 2017 |
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Main ID: |
ISRCTN67027605 |
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Date of registration:
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25/03/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A pilot proposal to determine the effect of the airsonett airshower on sleep quality
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Scientific title:
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A single-blind placebo-controlled trial to determine the effect of the airsonett airshower on sleep quality |
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Date of first enrolment:
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24/03/2011 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN67027605 |
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Study type:
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Interventional |
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Study design:
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Single-blind placebo-controlled trial (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Robert
Boyle |
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Address:
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Clinical Senior Lecturer in Paediatric Allergy
Imperial College London - St. Mary's Campus
Department of Paediatrics
Wright Fleming Building
Norfolk Place
W2 1PG
London
United Kingdom |
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Telephone:
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+44 (0)20 7594 3990 |
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Email:
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r.boyle@nhs.net |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Age 18-65
2. Doctor-diagnosed allergic rhinitis
3. Sensitised to house dust mite, cat or dog
4. Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire more than or equal to 3
Exclusion criteria: 1. Current smoker
2. Moderate/severe asthma
3. Current medication which cannot be stopped and may affect allergic inflammation or sleep
4. Body mass index (BMI) > 30
5. Known sickle cell disease
6. Adenotonsillar hypertrophy
7. Current immunotherapy
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Allergic rhinitis
Respiratory
Allergic rhinitis, unspecified
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Intervention(s)
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1. Four nights of study ? two with placebo Protexo device and two with active Protexo device
2. Allerguard pillow protectors to be used on all four nights
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Primary Outcome(s)
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Total nasal symptom score (itching, sneezing, rhinorrhoea, congestion rated as none=0, mild=1, moderate=2, severe=3)
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Secondary Outcome(s)
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1. Arousal index as measured by polysomnography
2. Other polysomnography parameters
3. Spirometry
4. Exhaled NO, nasal NO as measured by NIOX MINO device
5. Peak nasal inspiratory flow
6. Nasal inflammometry ? nasal secretions collected bilaterally using filter paper strips (7x30 mm)
7. Somnomat
8. Visual analogue scale for sleepiness ? 100 mm scale from extremely sleepy (0 mm) to not sleepy at all (100 mm)
9. Visual analogue scale for sleep quality ? 100 mm scale from worst night?s sleep ever (0 mm) to best night?s sleep ever (100 mm)
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Secondary ID(s)
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11/MRE00/6
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Source(s) of Monetary Support
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Imperial College London (UK)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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