Condition category
Nervous System Diseases
Date applied
12/01/2012
Date assigned
28/02/2012
Last edited
07/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Chung-Yao Hsu

ORCID ID

Contact details

No.100
Tzyou 1st Road
Kaohsiung
80754
Taiwan

Type

Scientific

Additional contact

Dr Renata Riha

ORCID ID

Contact details

51 Little France Crescent
Old Dalkeith Road
Edinburgh
EH16 4SA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Napping Behaviour in Sleep Apnoea (NBSA):– a randomised transcultural study in older people

Acronym

NBSA

Study hypothesis

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

South East Scotland Research Ethics Committee 01, 21/02/2012, ref: 12/SS/0017

Study design

Randomised single-blind parallel study

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

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

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

15/02/2012

Overall trial end date

31/10/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

30 in United Kingdom, 30 in Taiwan

Participant 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%

Recruitment start date

15/02/2012

Recruitment end date

31/10/2012

Locations

Countries of recruitment

Taiwan, United Kingdom

Trial participating centre

No.100, Tzyou 1st Road
Kaohsiung
80754
Taiwan

Sponsor information

Organisation

Kaohsiung Medical University Hospital (Taiwan)

Sponsor details

100
Shih-Chuan 1st Road
Kaohsiung
80708
Taiwan

Sponsor type

Hospital/treatment centre

Website

http://www.kmuh.org.tw

Organisation

Department of International Cooperation (Taiwan)

Sponsor details

National Science Council
Rm2205 106 Ho-Ping E. Rd. Sec. 2
Taipei
10622
Taiwan

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

National Science Council (NSC 99-2911-I-037-004)

Alternative name(s)

National Science Council, Taiwan, National Science Council of Taiwan, NSC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Taiwan

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

07/04/2016: Plain English summary added.