Sleep DisorderPIPQoRNCT06008873

Association Between Preoperative Insomnia and Postoperative Quality of Recovery : A Prospective Observational Study

An observational study of Sleep Disorder, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 64 years
Conditions the study is for: Sleep Disorder
How many people: 198 participants
Where: 1 siteChina
Study dates: 15 Feb 2023to 10 Sep 2023
Phase: Observational
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 to 64 years
All sexes
No healthy volunteers
Adult

Study population: Referred to the Eligibility Criteria for details.

Who may be able to join

1.Voluntarily execute informed consent;
2.Effective linguistic communication and collaboration;
3.No history of mental disorders;
4.Age of 18-64 years old, male or female;
5.BMI 18-30kg/m2;
6.American Society of anesthesiology (ASA) grade 1-2, New York Heart Association(NYHA) grade Ⅰ or Ⅱ;

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7.Initial diagnosis of abdominal cancers and the diagnosis has been disclosed to subjects;
8.Non-emergency cancer resection surgery is planned;
9.The planned anesthesia is general anesthesia with endotracheal intubation.

Who cannot join

1.Obstructive apnea syndrome, narcolepsy, restless leg/periodic limb movement disorder, sleepwalking disorder, nightmare disorder;
2.Not suitable to participate in the study.

Trial locations and contacts

1 site in 1 country.

China1 site

the Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510655

Other trials in China

About this study

Official title: Association Between Preoperative Insomnia and Postoperative Quality of Recovery in Non-elderly Patients Undergoing Non-emergency Cancer Resection Surgery: A Prospective Observational Study

Although patients with cancers are prone to insomnia, especially waiting for surgery during hospitalization, and insomnia promotes acute respiratory infections (ARI) and is not conducive to the postoperative quality of recovery (QoR), evidence that preoperative insomnia delays postoperative recovery is still lacking. In this prospective observational study, we enroll 175 non-elderly subjects with abdominal cancer who will undergo non-emergency cancer resection surgery. Insomnia Severity Index scale (ISI) is used to assess the insomnia severity during hospitalization while awaiting surgery. The Quality of Recovery-15 (QoR-15) is used to evaluate the overall recovery after surgery. Meanwhile, wrist watch and sleep diary are used to record sleep. The aim of the study is to investigate the association between preoperative insomnia and postoperative QoR, the association between preoperative insomnia and postoperative ARI,and to describe preoperative sleep traits.

Read the detailed description

In the single-center, prospective observational study, ISI is used to investigate the perceptive sleep during hospitalization waiting for surgery,and QoR-15 is used to investigate the overall quality of functional recovery at postoperative 1, 3, 7, 14, and 30 days (POD1/3/7/14/30). At the same time, both of ARI within POD30 and neutrophil to lymphocyte ratio(NLR) in peripheral blood perioperation are recorded. The study is divided into four phases: (1) Screening: on the first day of admission, the subjects are screened according to the inclusion and exclusion criteria, and the basic data are collected, including ISI, QoR-15 and depression/anxiety questionnaires, et al. (2) Enrollment (sleep survey during hospitalization waiting for surgery) : ISI is performed in the day of surgery to perceive the severity of insomnia during the whole period of hospitalization waiting for surgery, and objective and subjective sleep are investigated by wrist watch and sleep diary. (3) Surgical and anesthesia period: the key medical data related to surgery, anesthesia and nursing occurred during the operation are recorded. (4) Follow-up: QoR-15 is investigated POD1/3/7/14/30. Meanwhile, both of ARI and NLR are investigated.

The planned enrollment is 175 subjects. No randomized or any protocol-driven treatment is administered to the subjects during the study. The effect size f2 of the independent variable (ISI scores of hospitalization waiting for surgery) on the dependent variable (QoR-15 on POD1) is expected to be 0.1. The number of covariates is predicted to be 46, α is set as two-sided 0.05, and the power is 0.9. The sample size calculated by PASS software is 157 cases. Considering 10% dropout, a sample size of 175 will be required. Data will be presented as mean±standard deviation, median and number (%). Logistic multivariate, or multivariable models will be both performed by statisticians.

Conditions: Sleep Disorder
Keywords: Insomnia, Perioperative Medicine, cancer, surgery, Quality of Recovery
Medical subject headings: Sleep Wake Disorders, Sleep Initiation and Maintenance Disorders, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06008873
Study group	Role	What they receive
One group only		No intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

Total scores of the questionnaire of Insomnia Severity Scale (ISI) on the day before surgery or the day of surgery
ISI is used to assess insomnia during the time when waiting for surgery in hospital from the day of admission to the day of surgery.
ISI is used to assess how satisfied with sleep patterns and psychological distress or impairments in daytime functioning associated with sleep difficulties.
ISI is filled in by subjects on the day before surgery or the day of surgery. ISI contents 7 items, which item is measured by an 0-4 point rating scale (0="very satisfaction"; 4="very dissatisfaction").
ISI total scores range from 0 to 28, with higher scores indicating higher severity of insomnia.
Measured: on the day before surgery or the day of surgery
Total scores of the questionnaire of 15-item Quality of Recovery scale (QoR-15）on postoperative day 1
QoR-15 is a patient-reported measure, and is used to assess global recovery quality after surgery physiologically and psychologically.
QoR-15 is filled on postoperative day 1. QoR-15 contents 15 items, which item is constructed by an 11-point numerical rating scale (for positive items, 0= "none of the time" to 10="all of the time"; for negative items the scoring was reversed). The total scores are ranging from 0(extremely poor QoR) to 150 (excellent QoR).
Measured: on postoperative day 1

Secondary outcomes (12)

Sleep-onset latency(min)(resulting from CSD): Distribution frequency of different degrees of sleep latency during the time when waiting for surgery in hospital from the day of admission to the day of surgery
A Consensus Sleep Diary (CSD) is used to asses subjective sleep quantity everyday when waiting for surgery in hospital from the day of admission to the day of surgery.
The CSD items assess sleep-onset latency (time taken to fall asleep), the number of awakenings, and the total duration of sleep. Subjects also allow to record factors that could influence sleep, including use of sleep medication.
Measured: Everyday when waiting for surgery in hospital from the day of admission to the day of surgery
Numbers of awakenings(resulting from CSD): Distribution of Numbers of awakenings during the time when waiting for surgery in hospital from the day of admission to the day of surgery
A Consensus Sleep Diary (CSD) is used to asses subjective sleep quantity everyday waiting for surgery in hospital from the day of admission to the day of surgery.
The CSD items assess sleep-onset latency (time taken to fall asleep), the number of awakenings, and the total duration of sleep. Subjects also allow to record factors that could influence sleep, including use of sleep medication.
Measured: Everyday when waiting for surgery in hospital from the day of admission to the day of surgery
Total duration of sleep in night(min)(resulting from CSD): Distribution of total duration of sleep in night during the time when waiting for surgery in hospital from the day of admission to the day of surgery
A Consensus Sleep Diary (CSD) is used to asses subjective sleep quantity everyday waiting for surgery in hospital from the day of admission to the day of surgery.
The CSD items assess sleep-onset latency (time taken to fall asleep), the number of awakenings, and the total duration of sleep. Subjects also allow to record factors that could influence sleep, including use of sleep medication.
Measured: Everyday when waiting for surgery in hospital from the day of admission to the day of surgery
Sleep influencing factors(resulting from CSD): Distribution of factors that could influence sleep in night when waiting for surgery in hospital from the day of admission to the day of surgery
A Consensus Sleep Diary (CSD) is used to asses subjective sleep quantity everyday waiting for surgery in hospital from the day of admission to the day of surgery.
The CSD items assess sleep-onset latency (time taken to fall asleep), the number of awakenings, and the total duration of sleep. Subjects also allow to record factors that could influence sleep, including use of sleep medication.
Measured: Everyday when waiting for surgery in hospital from the day of admission to the day of surgery
Total scores of the questionnaire of 15-item Quality of Recovery scale (QoR-15）on postoperative day 3
QoR-15 is a patient-reported measure, and is used to assess global recovery quality after surgery physiologically and psychologically.
QoR-15 is filled on postoperative day 1. QoR-15 contents 15 items, which item is constructed by an 11-point numerical rating scale (for positive items, 0= "none of the time" to 10="all of the time"; for negative items the scoring was reversed). The total scores are ranging from 0(extremely poor QoR) to 150 (excellent QoR).
Measured: on postoperative day 3
Total scores of the questionnaire of 15-item Quality of Recovery scale (QoR-15）on postoperative day 7
QoR-15 is a patient-reported measure, and is used to assess global recovery quality after surgery physiologically and psychologically.
QoR-15 is filled on postoperative day 1. QoR-15 contents 15 items, which item is constructed by an 11-point numerical rating scale (for positive items, 0= "none of the time" to 10="all of the time"; for negative items the scoring was reversed). The total scores are ranging from 0(extremely poor QoR) to 150 (excellent QoR).
Measured: on postoperative day 7
Total scores of the questionnaire of 15-item Quality of Recovery scale (QoR-15）on postoperative day 14
QoR-15 is a patient-reported measure, and is used to assess global recovery quality after surgery physiologically and psychologically.
QoR-15 is filled on postoperative day 1. QoR-15 contents 15 items, which item is constructed by an 11-point numerical rating scale (for positive items, 0= "none of the time" to 10="all of the time"; for negative items the scoring was reversed). The total scores are ranging from 0(extremely poor QoR) to 150 (excellent QoR).
Measured: on postoperative day 14
Total scores of the questionnaire of 15-item Quality of Recovery scale (QoR-15）on postoperative day 30
QoR-15 is a patient-reported measure, and is used to assess global recovery quality after surgery physiologically and psychologically.
QoR-15 is filled on postoperative day 1. QoR-15 contents 15 items, which item is constructed by an 11-point numerical rating scale (for positive items, 0="none of the time" to 10="all of the time"; for negative items the scoring was reversed). The total scores are ranging from 0(extremely poor QoR) to 150 (excellent QoR).
Measured: on postoperative day 30
Incidence rate of Acute Respiratory Tract Infection (ARTI) within postoperative day 30
Acute Respiratory Tract Infection (ARTI): including acute upper respiratory infection and acute lower respiratory infection, according to patients self-reporting.
Measured: within postoperative day 30
Peripheral blood neutrophil/lymphocyte ratio on postoperative day 1
Peripheral blood neutrophil/lymphocyte ratio on postoperative day 1 resulting from blood routine examination
Measured: on postoperative day 1
Peripheral blood neutrophil/lymphocyte ratio on postoperative day 3
Peripheral blood neutrophil/lymphocyte ratio on postoperative day 3 from blood routine examination
Measured: on postoperative day 3
Peripheral blood neutrophil/lymphocyte ratio on postoperative day 7
Peripheral blood neutrophil/lymphocyte ratio on postoperative day 7 from blood routine examination
Measured: on postoperative day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Feb 202310 Sep 2023

First posted24 Aug 2023
Study start15 Feb 2023
Primary completion12 Aug 2023
Study completion10 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Sleep DisorderStudies of the same condition, open and under way.
More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe sponsor's other registered studies.
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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 198 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06008873
Sponsor's protocol ID: 2023ZSLYEC-260
Acronym: PIPQoR
Status last verified: Apr 2025
First submitted: 13 Aug 2023
Last updated: 6 Apr 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Association Between Preoperative Insomnia and Postoperative Quality of Recovery in Non-elderly Patients Undergoing Non-emergency Cancer Resection Surgery: A Prospective Observational Study
ClinicalTrials.gov ID: NCT06008873
Acronym / sponsor ID: PIPQoR / 2023ZSLYEC-260
Conditions: Sleep Disorder
Keywords: Insomnia, Perioperative Medicine, cancer, surgery, Quality of Recovery
Study type: Observational
Recruitment status: Completed
Enrolment: 198 participants (actual)
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
Study start: 15 Feb 2023 (actual)
Primary completion: 12 Aug 2023 (actual)
Study completion: 10 Sep 2023 (actual)
First posted: 24 Aug 2023 (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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
One group only	–	–No intervention.

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult
Study population: Referred to the Eligibility Criteria for details.

Key inclusion criteria (9 listed)

1.Voluntarily execute informed consent;
2.Effective linguistic communication and collaboration;
3.No history of mental disorders;
4.Age of 18-64 years old, male or female;
5.BMI 18-30kg/m2;

Key exclusion criteria (2 listed)

1.Obstructive apnea syndrome, narcolepsy, restless leg/periodic limb movement disorder, sleepwalking disorder, nightmare disorder;
2.Not suitable to participate in the study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Total scores of the questionnaire of Insomnia Severity Scale (ISI) on the day before surgery or the day of surgery
Time frame: on the day before surgery or the day of surgery
ISI is used to assess insomnia during the time when waiting for surgery in hospital from the day of admission to the day of surgery. ISI is used to assess how satisfied with sleep patterns and psychological distress or impairments in daytime functioning associated with sleep difficulties. ISI is filled in by subjects on the day before surgery or the day of surgery. ISI contents 7 items, which item is measured by an 0-4 point rating scale (0="very satisfaction"; 4="very dissatisfaction"). ISI total scores range from 0 to 28, with higher scores indicating higher severity of insomnia.
Total scores of the questionnaire of 15-item Quality of Recovery scale (QoR-15）on postoperative day 1
Time frame: on postoperative day 1
QoR-15 is a patient-reported measure, and is used to assess global recovery quality after surgery physiologically and psychologically. QoR-15 is filled on postoperative day 1. QoR-15 contents 15 items, which item is constructed by an 11-point numerical rating scale (for positive items, 0= "none of the time" to 10="all of the time"; for negative items the scoring was reversed). The total scores are ranging from 0(extremely poor QoR) to 150 (excellent QoR).

12 secondary outcomes

Sleep-onset latency(min)(resulting from CSD): Distribution frequency of different degrees of sleep latency during the time when waiting for surgery in hospital from the day of admission to the day of surgery
Time frame: Everyday when waiting for surgery in hospital from the day of admission to the day of surgery
Numbers of awakenings(resulting from CSD): Distribution of Numbers of awakenings during the time when waiting for surgery in hospital from the day of admission to the day of surgery
Time frame: Everyday when waiting for surgery in hospital from the day of admission to the day of surgery
Total duration of sleep in night(min)(resulting from CSD): Distribution of total duration of sleep in night during the time when waiting for surgery in hospital from the day of admission to the day of surgery
Time frame: Everyday when waiting for surgery in hospital from the day of admission to the day of surgery
Sleep influencing factors(resulting from CSD): Distribution of factors that could influence sleep in night when waiting for surgery in hospital from the day of admission to the day of surgery
Time frame: Everyday when waiting for surgery in hospital from the day of admission to the day of surgery
Total scores of the questionnaire of 15-item Quality of Recovery scale (QoR-15）on postoperative day 3
Time frame: on postoperative day 3
Total scores of the questionnaire of 15-item Quality of Recovery scale (QoR-15）on postoperative day 7
Time frame: on postoperative day 7
Total scores of the questionnaire of 15-item Quality of Recovery scale (QoR-15）on postoperative day 14
Time frame: on postoperative day 14
Total scores of the questionnaire of 15-item Quality of Recovery scale (QoR-15）on postoperative day 30
Time frame: on postoperative day 30
Incidence rate of Acute Respiratory Tract Infection (ARTI) within postoperative day 30
Time frame: within postoperative day 30
Peripheral blood neutrophil/lymphocyte ratio on postoperative day 1
Time frame: on postoperative day 1
Peripheral blood neutrophil/lymphocyte ratio on postoperative day 3
Time frame: on postoperative day 3
Peripheral blood neutrophil/lymphocyte ratio on postoperative day 7
Time frame: on postoperative day 7

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 6 Apr 2025.
Individual participant dataSharing planned: No

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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.

Jin sanqing, MD principal investigator

Sixth Affiliated Hospital, Sun Yat-sen University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Sleep Disorder, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.

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 9 inclusion and 2 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 6 Apr 2025. 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 China. 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?

Total scores of the questionnaire of Insomnia Severity Scale (ISI) on the day before surgery or the day of surgery (time frame: on the day before surgery or the day of surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06008873.

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 6 Apr 2025.