Effect of mouth taping at night on asthma control

ISRCTN	ISRCTN74428617
DOI	https://doi.org/10.1186/ISRCTN74428617
Secondary identifying numbers	TC03/5

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mrs Sue Cooper
Scientific

Division Respiratory Medicine
Clinical Sciences Building
City Hospital
Nottingham
NG5 1PB
United Kingdom

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Scientific title
Study objectives	Taping the mouth at night to ensure nose breathing will improve asthma control
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Asthma
Intervention	Crossover design of taping mouth at night versus usual breathing
Intervention type	Other
Primary outcome measure	Morning peak expiratory flow and symptom scores
Secondary outcome measures	1. Evening peak flow 2. Diurnal variation in peak flow 3. FEV1 4. Beta-agonist use 5. Night time waking 6. Quality of life 7. Acceptability 8. Compliance with taping
Overall study start date	27/05/2004
Completion date	31/05/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	72 Years
Sex	Both
Target number of participants	60
Key inclusion criteria	1. Asthma 2. Age 18-72 3. Forced expiratory volume in one second (FEV1) over 50% predicted 4. Nocturnal or early morning symptoms 5. Pro re nata (prn) (as needed) beta-agonist use
Key exclusion criteria	1. Previous training in Buteyko technique 2. Inability to breathe through nose 3. Known sleep apnoea 4. Over 10 pack years smoking history 5. Other significant uncontrolled disease
Date of first enrolment	27/05/2004
Date of final enrolment	31/05/2006

Division Respiratory Medicine

Nottingham
NG5 1PB
United Kingdom

University of Nottingham (UK)
University/education

Research Innovation Services
University Park
Nottingham
NG7 2RD
England
United Kingdom

Email	paul.cartledge@nottingham.ac.uk
"ROR"	https://ror.org/01ee9ar58

Charity

British Lung Foundation (UK) - )ref: TC03/5)
Private sector organisation / Trusts, charities, foundations (both public and private)

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2009		Yes	No