None listed
Conditions
Brief summary
Obstructive sleep apnoea (OSA) is a disorder characterised by repetitive obstruction of the throat during sleep. People who suffer from OSA have increased risk of heart disease and are often very tired during the daytime. Currently, continuous positive airway pressure (CPAP) is the most common treatment for OSA because it treats the disorder in almost all patients. Many patients, however, do not like using CPAP for several reasons (for example it is bulky, or is uncomfortable), and therefore choose not to use it. For this reason, we wish to find an alternative treatment that is effective and well tolerated by patients. A recent research paper has suggested that acupuncture can lower the severity of OSA. However, the authors did not investigate how acupuncture caused the change in OSA severity. Our study aims to 1) see whether acupuncture treats OSA, and 2) try and work out how acupuncture is improving the severity of OSA. It is hypothesized that patients will experience fewer respiratory events and experience less daytime sleepiness after twelve treatments of acupuncture, but that placebo acupuncture will have no effect on the severity of OSA or sleepiness. It is also hypothesized that for those patients who experience reductions in the severity of their OSA symptoms will show changes in the activity of the airway muscles, changes in the resistance to airflow in their throat and changes in the amount of effort required to wake them from sleep while they are having a respiratory event.
Interventions
Acupuncture:
Study Duration: the whole study will take 15 weeks starting from the screening, and including the baseline and end measurement sessions as well as twelve acupuncture treatment sessions.
Intervention: each acupuncture treatment session will be one hour in duration with a total of 12 treatment sessions (2 x bi-weekly treatments for two weeks, 1 x weekly treatments for the next 6 weeks and finally 2 x fortnightly treatments for the next four weeks).
Mode of administration: The acupu
Acupuncture: Study Duration: the whole study will take 15 weeks starting from the screening, and including the baseline and end measurement sessions as well as twelve acupuncture treatment sessions. Intervention: each acupuncture treatment session will be one hour in duration with a total of 12 treatment sessions (2 x bi-weekly treatments for two weeks, 1 x weekly treatments for the next 6 weeks and finally 2 x fortnightly treatments for the next four weeks). Mode of administration: The acupuncture treatment involves single-use disposable acupuncture needles that vary between 13-40mm in length and 0.18-0.25mm in diameter. The points of application will vary depending on the stage of treatment but will be points that regulate activity of the respiratory tract, and tonify the Spleen, Kidneys and Lungs.
Sponsors
Dr. Amy Jordan
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Mild to moderate OSA (AHI between 5 and 30) Not currently receiving treatment for obstructive sleep apnoea Acupuncture naive (as defined as not having previously experienced acupuncture treatment)
Exclusion criteria
Excessive daytime sleepiness. Pregnant women. Individuals dependent on a carer or guardian. Individuals unable by reason of cognitive impairment, or inadequate English language skill to give informed consent. Individuals with concurrent sleep disorders other than OSA or a co-morbid condition that is a significant threat to mortality or significantly alters respiratory or cardiovascular anatomy or physiology (e.g., patients who have had an acute cardiac or cerebral event in the previous 3 month, or patients with cardiac disease and oxygen saturation less than 90% for more than 10 minutes during sleep). Individuals for whom withholding treatment would lead to a significant risk to them or the general population (e.g., bus/taxi drivers or heavy machinery operators, those with severe daytime sleepiness - defined as Epworth Sleepiness Score >16, or those in whom, in the opinion of their treating physician, it is unsafe to withold definitive treatment for a period of 15 weeks).
Outcome results
None listed