Condition category
Respiratory
Date applied
22/03/2011
Date assigned
25/03/2011
Last edited
22/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Robert Boyle

ORCID ID

Contact details

Clinical Senior Lecturer in Paediatric Allergy
Imperial College London - St. Mary's Campus
Department of Paediatrics
Wright Fleming Building
Norfolk Place
London
W2 1PG
United Kingdom
+44 (0)20 7594 3990
r.boyle@nhs.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

11/MRE00/6

Study information

Scientific title

A single-blind placebo-controlled trial to determine the effect of the airsonett airshower on sleep quality

Acronym

Study hypothesis

1. In adults with allergic rhinitis sensitised to dust mite, cat or dog and with significant rhinitis-related sleep disturbance (NRQLQ=3), treatment with nocturnal temperature-controlled laminar airflow (TLA) results in improved total symptom score compared to placebo device, on the second night of treatment.
2. In adults with allergic rhinitis sensitised to dust mite, cat or dog and with significant rhinitis-related sleep disturbance (NRQLQ=3), nocturnal TLA results in reduced nasal IL-5, reduced diurnal variation in peak nasal inspiratory flow, reduced nasal nitric oxide (NO), reduced modified NRQLQ score (i.e. scored over past 48 hours rather than 1 week), improved sleep parameters as measured by polysomnography and the Somnomat.

Ethics approval

Scotland A Research Ethics Committee, 28/02/2011, ref: 11/MRE00/6

Study design

Single-blind placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

Allergic rhinitis

Intervention

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

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Total nasal symptom score (itching, sneezing, rhinorrhoea, congestion rated as none=0, mild=1, moderate=2, severe=3)

Secondary outcome measures

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)

Overall trial start date

24/03/2011

Overall trial end date

26/05/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

10

Participant 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

Recruitment start date

24/03/2011

Recruitment end date

26/05/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Clinical Senior Lecturer in Paediatric Allergy
London
W2 1PG
United Kingdom

Sponsor information

Organisation

Airsonett AB (Sweden)

Sponsor details

Metallgatan 33
Ängelholm
SE 262 72
Sweden
+46 (0)4 314 025 30
info@airsonett.com

Sponsor type

Industry

Website

http://www.airsonett.com/

Funders

Funder type

University/education

Funder name

Imperial College London (UK)

Alternative name(s)

ICL

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes