Sleep Apnea, ObstructiveNCT06249295
Postoperative Oral Cryotherapy in Sore Throat and Daily Life
A study testing oral cryotherapy in people with Sleep Apnea, Obstructive, run by Chung Shan Medical University at 1 site in Taiwan.
Trial summary
The purpose of this study will to evaluate the degree of postoperative sore throat and Life Impairment changes in patients with sleep apnea who underwent da Vinci robotic arm surgery as an intervention of oral cryotherapy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- oral cryotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTaiwan
- Study dates
- 31 Jan 2024to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- (1)Admission age is 18 years or above, conscious, able to communicate in Mandarin and Taiwanese, and willing to be measured and fill out the questionnaire after explaining the process and purpose of the study.
- (2) The study was conducted in hospitalised patients diagnosed with sleep apnea who underwent surgery.
Who cannot join
- (1) Diagnostic diagnosis of the disease not clearly known.
- (2) Patients with unclear consciousness.
- (3) Patients who have been diagnosed with mental illness before the diagnosis of the -
- disease or recently diagnosed with mental illness.
- (4) People with paraplegia or low behavioural ability.
- (5) Patients who have suffered a stroke.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Postoperative Oral Cryotherapy in Sore Throat and Daily Life in Patients With Sleep Apnea
The purpose of this study will to evaluate the degree of postoperative sore throat and Life Impairment changes in patients with sleep apnea who underwent da Vinci robotic arm surgery as an intervention of oral cryotherapy.
Read the detailed description
An experimental study was conducted with 32 patients in the experimental group and 32 patients in the control group. The experimental group used drinking water from a water dispenser with regular filter replacement and maintenance, plus a 2x5x7 cm (50 ml) ice lolly module to make ice lollies,and then intervened in the postsurgical period using oral cold therapy (ice lolly in the mouth),while the control group received general routine care. The control group received regular care. The assessment tools included the Pain Profile Scale and the Life Impairment Scale, and the assessment period was from the first day to the 14th day after the operation.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- oral cryotherapy
- Keywords
- Obstructive sleep apnea syndrome, oral cryotherapy, pain, daily life
- Medical subject headings
- Sleep Apnea, Obstructive, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral cryotherapyOther
The experimental group used drinking water from a water dispenser with regular filter replacement and maintenance, plus a 2x5x7 cm (50 ml) ice lolly module to make ice lollies, and then intervened in the post-surgical period using oral cold therapy (ice lolly in the mouth)
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The experimental group used drinking water from a water dispenser with regular filter replacement and maintenance, plus a 2x5x7 cm (50 ml) ice lolly module to make ice lollies, and then intervened in the post-surgical period using oral cold therapy (ice lolly in the mouth). Receives: Other: oral cryotherapy |
| control group | No intervention | The control group received general routine care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
sore throat
The Pain Profile Scale assesses the pain level of the patient, which consists of 8 items: total pain level, throat pain level, throat pain during swallowing, ear pain during swallowing, difficulty swallowing, limitation of physical activity, oral odor, and sleep disruption, and other symptoms related to pain. The scoring criteria are based on a four-point scale: 0 for no sensation, 1 for mild, 2 for The scale is based on a four-point scale: 0 for no sensation, 1 for mild, 2 for moderate, and 3 for severe to present a multidimensional pain assessment.
Measured: up to 2 weeks
Secondary outcomes (1)
daily life
The secondary outcome was to measure the extent to which the level of physical pain interfered with daily life, with a scale of 1 as not at all interfered, 2 as somewhat interfering, 3 as moderately interfering, 4 as considerably interfering, and 5 as extremely interfering, to understand the impact of pain on daily life.
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start31 Jan 2024
- Primary completion31 Jan 2024
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The experimental group used drinking water from a water dispenser with regular filter replacement and maintenance, plus a 2x5x7 cm (50 ml) ice lolly module to make ice lollies ,and then intervened in the post-surgical period using oral cold therapy (ice lolly in the mouth), while the control group received general routine care.
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsiang Chu Pai, Chung Shan Medical University
- Investigators
- Hsiang Chu Pai, PhD, Study director, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06249295
- Sponsor's protocol ID
- CS1 21024
- Status last verified
- Feb 2025
- First submitted
- 30 Jan 2024
- Last updated
- 18 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Postoperative Oral Cryotherapy in Sore Throat and Daily Life in Patients With Sleep Apnea
- ClinicalTrials.gov ID
- NCT06249295
- Acronym / sponsor ID
- CS1 21024
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- Obstructive sleep apnea syndrome, oral cryotherapy, pain, daily life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 8 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study will to evaluate the degree of postoperative sore throat and Life Impairment changes in patients with sleep apnea who underwent da Vinci robotic arm surgery as an intervention of oral cryotherapy.
Detailed description
An experimental study was conducted with 32 patients in the experimental group and 32 patients in the control group. The experimental group used drinking water from a water dispenser with regular filter replacement and maintenance, plus a 2x5x7 cm (50 ml) ice lolly module to make ice lollies,and then intervened in the postsurgical period using oral cold therapy (ice lolly in the mouth),while the control group received general routine care. The control group received regular care. The assessment tools included the Pain Profile Scale and the Life Impairment Scale, and the assessment period was from the first day to the 14th day after the operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The experimental group used drinking water from a water dispenser with regular filter replacement and maintenance, plus a 2x5x7 cm (50 ml) ice lolly module to make ice lollies ,and then intervened in the post-surgical period using oral cold therapy (ice lolly in the mouth), while the control group received general routine care.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: oral cryotherapyThe experimental group used drinking water from a water dispenser with regular filter replacement and maintenance, plus a 2x5x7 cm (50 ml) ice lolly module to make ice lollies, and then intervened in the post-surgical period using oral cold therapy (ice lolly in the mouth). |
| control group | No intervention | –The control group received general routine care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- (1)Admission age is 18 years or above, conscious, able to communicate in Mandarin and Taiwanese, and willing to be measured and fill out the questionnaire after explaining the process and purpose of the study.
- (2) The study was conducted in hospitalised patients diagnosed with sleep apnea who underwent surgery.
Key exclusion criteria (6 listed)
- (1) Diagnostic diagnosis of the disease not clearly known.
- (2) Patients with unclear consciousness.
- (3) Patients who have been diagnosed with mental illness before the diagnosis of the -
- disease or recently diagnosed with mental illness.
- (4) People with paraplegia or low behavioural ability.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral cryotherapyThe experimental group used drinking water from a water dispenser with regular filter replacement and maintenance, plus a 2x5x7 cm (50 ml) ice lolly module to make ice lollies, and then intervened in the post-surgical period using oral cold therapy (ice lolly in the mouth) | Other | Intervention group |
Primary outcome
sore throat
Time frame: up to 2 weeks
The Pain Profile Scale assesses the pain level of the patient, which consists of 8 items: total pain level, throat pain level, throat pain during swallowing, ear pain during swallowing, difficulty swallowing, limitation of physical activity, oral odor, and sleep disruption, and other symptoms related to pain. The scoring criteria are based on a four-point scale: 0 for no sensation, 1 for mild, 2 for The scale is based on a four-point scale: 0 for no sensation, 1 for mild, 2 for moderate, and 3 for severe to present a multidimensional pain assessment.
1 secondary outcome
daily life
Time frame: up to 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
Related trials for Sleep Apnea, Obstructive
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hsiang Chu Pai, PhD study director
Chung Shan Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral cryotherapy in people with Sleep Apnea, Obstructive, run by Chung Shan Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sore throat (time frame: up to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.