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Mouth Breathing Habits Improvement Intervention

N

National Yang Ming Chiao Tung University

Status

Completed

Conditions

OSA

Treatments

Other: Oral Appliances

Study type

Interventional

Funder types

Other

Identifiers

NCT05404438
YM107083E

Details and patient eligibility

About

This study intends to investigate the improvement in patients with OSA through objective measurement, including oxygen desaturation index (ODI) and the percentage reduction in intermittent mouth puffing (IMP) before and after the intervention. The oral appliances are placed between the tongue and the soft palate to reduce the oral ventilation space. A total of 24 participants aged between 36 and 57 years were identified with ODI above 5 events/hour by measuring their blood oxygen and with an originally designed mouth puffing detector to find out those who were still mouth-puffed when their mouths were taped. A suitable appliance was chosen for the participants between the two originally designed oral appliances, tongue pressed device (TPD) and tongue elevated device (TED), and the intervention lasted for six weeks.

Enrollment

24 patients

Sex

All

Ages

20 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • (1) aged 20-60 years old,
  • (2) having symptoms of OSA including snoring, daytime sleepiness, etc.
  • (3) AHI & ODI >=5 events/hour,

Exclusion criteria

  • (1) taken sleep medication within the last two months or were on long-term use,
  • (2) reported tobacco, alcohol, caffeine or drug addiction,
  • (3) cancer, cardiovascular disease, psychiatric illness, kidney disease, diabetes mellitus, or other sleep disorders.

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

24 participants in 1 patient group

intervention group
Experimental group
Description:
single arm study
Treatment:
Other: Oral Appliances

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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