Effect of mouth taping at night on asthma control

ISRCTN	ISRCTN74428617
DOI	https://doi.org/10.1186/ISRCTN74428617
Protocol serial number	TC03/5
Sponsor	University of Nottingham (UK)
Funder	British Lung Foundation (UK) - )ref: 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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	Morning peak expiratory flow and symptom scores
Key secondary outcome measure(s)	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
Completion date	31/05/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	72 Years
Sex	All
Target sample size at registration	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

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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