Napping behaviour in sleep apnoea: a transcultural study in older people
| ISRCTN | ISRCTN61998123 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61998123 |
| Secondary identifying numbers | N/A |
- Submission date
- 12/01/2012
- Registration date
- 28/02/2012
- Last edited
- 07/04/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
Obstructive sleep apnoea syndrome (OSAS) is a condition where the walls of the throat relax and narrow during sleep, interrupting normal breathing. These repeated sleep interruptions can make patients with OSAS feel very tired during the day, causing them to take frequent naps. OSAS can be treated with continuous positive airway pressure (CPAP). This involves wearing a mask that delivers a continuous supply of compressed air that prevents the throat from closing. The aim of this study is to examine the effect of CPAP on napping behaviour in OSAS patients in two different ethnic populations.
Who can participate?
Scottish and Taiwanese patients with OSAS, aged 60 and over, who nap at least 3 times per week with average nap duration of at least 30 minutes.
What does the study involve?
Patients are randomly allocated to one of two groups. One group is treated with CPAP and best supportive care for 12 weeks. The other group is treated with best supportive care for 6 weeks, then CPAP and best supportive care for another 6 weeks. Best supportive care includes normal medical treatment and information about weight loss, stopping smoking, drinking less alcohol, changing sleeping posture and sleep hygiene. Both groups undergo tests at the start of the study and at follow-up. The tests evaluate sleep behaviour, mood and anxiety, and quality of life. All participants undergo 2 weeks of actigraphy (sleep monitoring) before hospital visits. Sleep diaries are recorded over the study period.
What are the possible benefits and risks of participating?
All participants receive detailed advice on managing their OSAS with improved diet, exercise and regular sleep patterns. We may find during the tests that something needs further investigation or treatment that would not have otherwise been found. CPAP is generally very well tolerated. Sometimes it can cause nasal dryness/discomfort, nasal discharge, a dry mouth (and dribbling), facial discomfort and, rarely, ulceration due to poor mask fitting. These effects can be minimised by the use of humidification and careful mask fitting.
Where is the study run from?
1. Royal Infirmary of Edinburgh (UK)
2. Kaohsiung Medical University Hospital (Taiwan)
When is the study starting and how long is it expected to run for?
February 2012 and October 2012
Who is funding the study?
National Science Council (Taiwan)
Who is the main contact?
Dr Chung-Yao Hsu
Contact information
Scientific
No.100, Tzyou 1st Road
Kaohsiung
80754
Taiwan
Scientific
51 Little France Crescent
Old Dalkeith Road
Edinburgh
EH16 4SA
United Kingdom
Study information
| Study design | Randomised single-blind parallel study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Napping Behaviour in Sleep Apnoea (NBSA): a randomised transcultural study in older people |
| Study acronym | NBSA |
| Study objectives | Napping behaviour in obstructive sleep apnoea (OSAS) patients may reflect a compensatory reaction to sleep deprivation or sleep interruption. If sleep deprivation or sleep interruption due to disturbed breathing improve after continuous positive airway pressure (CPAP) treatment, napping behaviour may decrease. |
| Ethics approval(s) | South East Scotland Research Ethics Committee 01, 21/02/2012, ref: 12/SS/0017 |
| Health condition(s) or problem(s) studied | Obstructive sleep apnoea syndrome (OSAS) |
| Intervention | 1. An early CPAP group: CPAP + best supportive care (BSC) for 12 weeks 2. A delayed CPAP group: BSC for 6 weeks initially then CPAP + BSC will be combined for another 6 weeks. BSC includes normal medical treatment and information about weight reduction, smoking cessation, reducing alcohol consumption, change in sleeping posture and sleep hygiene. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Change in weekly nap frequency and duration every 6 weeks in both groups |
| Secondary outcome measures | 1. CPAP compliance during CPAP intervention in both groups 2. Change in Epworth Sleepiness Scale (ESS) and Pittsburgh Sleep Quality Index (PSQI) scores 3. Change in RAND-36 scores 4. Change in Hospital Anxiety and Depression Scale (HADS) scores Measured every 6 weeks in both groups 5. Change in reaction time of Psychomotor Vigilance Task (PVT) assessed post intervention |
| Overall study start date | 15/02/2012 |
| Completion date | 31/10/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 30 in United Kingdom, 30 in Taiwan |
| Key inclusion criteria | 1. Aged 60 years and over 2. Have apnoea-hypopnoea index (AHI) ≥ 15 3. Nap at least 3 times per week with average nap duration of at least 30 minutes |
| Key exclusion criteria | 1. Have previous exposure to continuous positive airway pressure (CPAP) therapy 2. Are unable to give written informed consent or comply with the protocol 3. Are on central nervous system (CNS)-active drug treatment (e.g., hypnotic and antiepileptic drugs) that causes significant daytime sleepiness or cognitive impairment 4. Have an unstable medical or psychiatric illness 5. Have moderate to severe respiratory disease that affects activities of daily living or awake SpO2 less than 92% |
| Date of first enrolment | 15/02/2012 |
| Date of final enrolment | 31/10/2012 |
Locations
Countries of recruitment
- Taiwan
- United Kingdom
Study participating centre
80754
Taiwan
Sponsor information
Hospital/treatment centre
100, Shih-Chuan 1st Road
Kaohsiung
80708
Taiwan
| Website | http://www.kmuh.org.tw |
|---|
Government
National Science Council
Rm2205 106 Ho-Ping E. Rd. Sec. 2
Taipei
10622
Taiwan
Not defined
| Website | http://www.kmuh.org.tw/ |
|---|---|
"ROR" |
https://ror.org/02xmkec90 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Science Council, Taiwan, National Science Council of Taiwan, NSC
- Location
- Taiwan
Results and Publications
| 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 |
Editorial Notes
07/04/2016: Plain English summary added.
