Nasal Septal DeviationNCT01592123
Effects of Nasal Septal Surgery on Sleep Quality, Daytime and Dream Anxiety
An observational study of Nasal Septal Deviation, run by Ataturk Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this report was to assess the frequency of poor sleep quality, daytime and dream anxiety and their response to subsequent surgical treatment for a representative group patients with nasal septum deviation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nasal Septal Deviation
- What is being tested?
- The active anterior rhinomanometry, The Pittsburgh Sleep Quality Index (PSQI) and The Beck Anxiety Inventory (BAI)
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2010to Apr 2012
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Otorhinolaryngology outpatient clinic
Who may be able to join
- All participants, 18 to 65 years of age, had septal deviation consistent with the presenting symptoms which last at least three months and persist after a three months trial of medical management, including topical nasal steroids, topical or oral decongestants, or an oral antihistamine/decongestant combination.
Who cannot join
- Patients were excluded from the study if they had nasal septal surgery performed for other reasons, such as
- an access to nasal and sinus tumors,
- pituitary surgery and as part of treatment for sleep apnea or with concurrent sinus surgery;
- had rhinoplasty prior to submucous resection;
- had acute nasal trauma;
- had adenoid hypertrophy;
Show all 18Show fewer
- had uncontrolled asthma/nasal allergy;
- had diagnosed or suspected (snoring with/without other symptoms, such as apneas referred by someone and/or somnolence) OSA;
- had obesity (BMI ≥ 30.0 kg/m2);
- had an unstable physical disorder;
- had a current or lifetime history of any functional or organic mental disorder;
- had a history of seizures;
- had a neurological disorder that significantly affects central nervous system functions;
- had met criteria for substance abuse or dependence in the previous 12 months, including nicotine dependence;
- were taking medications that may cause or exacerbate sleep problems, daytime and dream anxiety; had clinical or laboratory evidence of hypothyroidism without adequate and stable replacement therapy;
- had a history of antidepressant or sedative-hypnotic medications for any current or past complaint;
- were pregnant or breastfeeding; or
- were women not using effective contraception.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ataturk University, Yakutiye Research Hospital
Erzurum, Yakutiye, 25240
About this study
Official title: Evaluation of Benefits of Nasal Septal Surgery on Subjective Sleep Quality, Daytime and Dream Anxiety
The aim of this report was to assess the frequency of poor sleep quality, daytime and dream anxiety and their response to subsequent surgical treatment for a representative group patients with nasal septum deviation.
Read the detailed description
Prior to the surgery, nasal airflows and airway resistances were measured employing rhinomanometry and they were also asked to fill in the Pittsburgh Sleep Quality Index (PSQI), the Beck Anxiety Inventory (BAI), and the Van Dream Anxiety Scale (VDAS). And, a postoperative assessment for the same parameters was made at two months from the day of the surgery.
- Conditions
- Nasal Septal Deviation
- Being tested
- The active anterior rhinomanometry, The Pittsburgh Sleep Quality Index (PSQI), The Beck Anxiety Inventory (BAI), The Van Dream Anxiety Scale (VDAS)
- Keywords
- anxiety, septal surgery, septum deviation, sleep
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The active anterior rhinomanometryProcedure or surgery
Also called Rhino 4000M (Homoth, Hamburg, Germany)
In this method, the airflow through 1 nasal cavity and the pressure gradient across this nasal cavity are measured simultaneously at each breath as recommended by the committee report on the standardization of rhinomanometry. All measurements were performed under the same standard conditions. Herein, all presented airflow values are the sum of inspiratory airflow of the right and left sides of the nose at 150 pascals (Pa). And, total nasal airflow (cm3/s) and airway resistance (Pa/cm3/s) values were used for statistical analyses.
The Pittsburgh Sleep Quality Index (PSQI)Behavioural
Also called The Pittsburgh Sleep Quality Index (Buysse et al., 1989)
PSQI was developed to measure sleep quality during the previous month and to discriminate between good and poor sleepers. The self-administered scale contains 15 multiple-choice items that inquire about frequency of sleep disturbances and subjective sleep quality and 4 write-in items that inquire about typical bedtime, wake-up time, sleep latency, and sleep duration. Each component score ranges from 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range of 0-21). A PSQI global score >5 is considered to be suggestive of significant sleep disturbance.
The Beck Anxiety Inventory (BAI)Behavioural
Also called The Beck Anxiety Inventory (Beck et al., 1988)
The BAI is a 21-item self-report questionnaire that lists symptoms of anxiety. The respondent is asked to rate how much each symptom has bothered him/her in the past week. The symptoms are rated on a four-point scale, ranging from ''not at all'' (0) to ''severely'' (3). The instrument has excellent internal consistency and high test-retest reliability. The BAI has been widely used to measure severity of anxiety by self-report.
The Van Dream Anxiety Scale (VDAS)Behavioural
Also called The Van Dream Anxiety Scale (Agargun et al., 1999)
The VDAS provides the assessment of nightmare frequency and dream anxiety caused by frightening dreams during the preceding month. There are 17 self-rated questions in the scale. Twelve questions (1-4, 6, 11-17) that are tabulated in the scoring are weighted equally on a 0-4 scale. Question 5 is related to autonomic hyperactivity and consists of 12 symptoms. Each of 12 symptoms is also weighted on a 0-4 scale. Thirteen question scores are summed to yield a global VDAS score, which has a range of 0-42.
| Study group | Role | What they receive |
|---|---|---|
| The participants with septal deviation | Not described Receives: Procedure: The active anterior rhinomanometry; Behavioral: The Pittsburgh Sleep Quality Index (PSQI); Behavioral: The Beck Anxiety Inventory (BAI); Behavioral: The Van Dream Anxiety Scale (VDAS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The amelioration of subjective sleep quality with nasal septal surgery.
The Pittsburgh Sleep Quality Index (PSQI) was used for the evaluations.
Measured: A postoperative assessment for the aforementioned parameter was made at two months from the day of the surgery.
The amelioration of daytime anxiety with nasal septal surgery.
The Beck Anxiety Inventory (BAI) was used for the evaluations.
Measured: A postoperative assessment for the aforementioned parameter was made at two months from the day of the surgery.
The amelioration of dream anxiety with nasal septal surgery.
The Van Dream Anxiety Scale (VDAS) was used for the evaluations.
Measured: A postoperative assessment for the aforementioned parameter was made at two months from the day of the surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2012 (estimated)
- Study startOct 2010
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nasal Septal DeviationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Gulec, M.D., Psych., Assist. Prof., Ataturk Training and Research Hospital
- Investigators
- Mustafa Gulec, investigator, Principal investigator, Ataturk University, Faculty of Medicine, Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01592123
- Sponsor's protocol ID
- MG-ATA-001
- Status last verified
- May 2012
- First submitted
- 30 Apr 2012
- Last updated
- 7 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Baumann I. Quality of life before and after septoplasty and rhinoplasty. GMS Curr Top Otorhinolaryngol Head Neck Surg. 2010;9:Doc06. doi: 10.3205/cto000070. Epub 2011 Apr 27.
PubMed 22073110Moore M, Eccles R. Objective evidence for the efficacy of surgical management of the deviated septum as a treatment for chronic nasal obstruction: a systematic review. Clin Otolaryngol. 2011 Apr;36(2):106-13. doi: 10.1111/j.1749-4486.2011.02279.x.
PubMed 21332671
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Benefits of Nasal Septal Surgery on Subjective Sleep Quality, Daytime and Dream Anxiety
- ClinicalTrials.gov ID
- NCT01592123
- Acronym / sponsor ID
- MG-ATA-001
- Conditions
- Nasal Septal Deviation
- Keywords
- anxiety, septal surgery, septum deviation, sleep
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Ataturk Training and Research HospitalUniversity, hospital or other
- Study start
- Oct 2010
- Study completion
- Apr 2012 (actual)
- First posted
- 7 May 2012 (estimated)
- 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 aim of this report was to assess the frequency of poor sleep quality, daytime and dream anxiety and their response to subsequent surgical treatment for a representative group patients with nasal septum deviation.
Detailed description
Prior to the surgery, nasal airflows and airway resistances were measured employing rhinomanometry and they were also asked to fill in the Pittsburgh Sleep Quality Index (PSQI), the Beck Anxiety Inventory (BAI), and the Van Dream Anxiety Scale (VDAS). And, a postoperative assessment for the same parameters was made at two months from the day of the surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The participants with septal deviation | – | Procedure: The active anterior rhinomanometry, Behavioral: The Pittsburgh Sleep Quality Index (PSQI), Behavioral: The Beck Anxiety Inventory (BAI), Behavioral: The Van Dream Anxiety Scale (VDAS) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Otorhinolaryngology outpatient clinic
Key inclusion criteria (1 listed)
- All participants, 18 to 65 years of age, had septal deviation consistent with the presenting symptoms which last at least three months and persist after a three months trial of medical management, including topical nasal steroids, topical or oral decongestants, or an oral antihistamine/decongestant combination.
Key exclusion criteria (18 listed)
- Patients were excluded from the study if they had nasal septal surgery performed for other reasons, such as
- an access to nasal and sinus tumors,
- pituitary surgery and as part of treatment for sleep apnea or with concurrent sinus surgery;
- had rhinoplasty prior to submucous resection;
- had acute nasal trauma;
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 |
|---|---|---|
| The active anterior rhinomanometryAlso: Rhino 4000M (Homoth, Hamburg, Germany)In this method, the airflow through 1 nasal cavity and the pressure gradient across this nasal cavity are measured simultaneously at each breath as recommended by the committee report on the standardization of rhinomanometry. All measurements were performed under the same standard conditions. Herein, all presented airflow values are the sum of inspiratory airflow of the right and left sides of the nose at 150 pascals (Pa). And, total nasal airflow (cm3/s) and airway resistance (Pa/cm3/s) values were used for statistical analyses. | Procedure or surgery | The participants with septal deviation |
| The Pittsburgh Sleep Quality Index (PSQI)Also: The Pittsburgh Sleep Quality Index (Buysse et al., 1989)PSQI was developed to measure sleep quality during the previous month and to discriminate between good and poor sleepers. The self-administered scale contains 15 multiple-choice items that inquire about frequency of sleep disturbances and subjective sleep quality and 4 write-in items that inquire about typical bedtime, wake-up time, sleep latency, and sleep duration. Each component score ranges from 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range of 0-21). A PSQI global score >5 is considered to be suggestive of significant sleep disturbance. | Behavioural | The participants with septal deviation |
| The Beck Anxiety Inventory (BAI)Also: The Beck Anxiety Inventory (Beck et al., 1988)The BAI is a 21-item self-report questionnaire that lists symptoms of anxiety. The respondent is asked to rate how much each symptom has bothered him/her in the past week. The symptoms are rated on a four-point scale, ranging from ''not at all'' (0) to ''severely'' (3). The instrument has excellent internal consistency and high test-retest reliability. The BAI has been widely used to measure severity of anxiety by self-report. | Behavioural | The participants with septal deviation |
| The Van Dream Anxiety Scale (VDAS)Also: The Van Dream Anxiety Scale (Agargun et al., 1999)The VDAS provides the assessment of nightmare frequency and dream anxiety caused by frightening dreams during the preceding month. There are 17 self-rated questions in the scale. Twelve questions (1-4, 6, 11-17) that are tabulated in the scoring are weighted equally on a 0-4 scale. Question 5 is related to autonomic hyperactivity and consists of 12 symptoms. Each of 12 symptoms is also weighted on a 0-4 scale. Thirteen question scores are summed to yield a global VDAS score, which has a range of 0-42. | Behavioural | The participants with septal deviation |
Primary outcome
The amelioration of subjective sleep quality with nasal septal surgery.
Time frame: A postoperative assessment for the aforementioned parameter was made at two months from the day of the surgery.
The Pittsburgh Sleep Quality Index (PSQI) was used for the evaluations.
The amelioration of daytime anxiety with nasal septal surgery.
Time frame: A postoperative assessment for the aforementioned parameter was made at two months from the day of the surgery.
The Beck Anxiety Inventory (BAI) was used for the evaluations.
The amelioration of dream anxiety with nasal septal surgery.
Time frame: A postoperative assessment for the aforementioned parameter was made at two months from the day of the surgery.
The Van Dream Anxiety Scale (VDAS) was used for the evaluations.
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 7 May 2012.
- Background: PubMed 22073110Baumann I. Quality of life before and after septoplasty and rhinoplasty. GMS Curr Top Otorhinolaryngol Head Neck Surg. 2010;9:Doc06. doi: 10.3205/cto000070. Epub 2011 Apr 27.
- Background: PubMed 21332671Moore M, Eccles R. Objective evidence for the efficacy of surgical management of the deviated septum as a treatment for chronic nasal obstruction: a systematic review. Clin Otolaryngol. 2011 Apr;36(2):106-13. doi: 10.1111/j.1749-4486.2011.02279.x.
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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.
Mustafa Gulec, investigator principal investigator
Ataturk University, Faculty of Medicine, Department of Psychiatry
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 Nasal Septal Deviation, run by Ataturk Training and Research Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 18 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 7 May 2012. 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 Turkey (Türkiye). 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?
The amelioration of subjective sleep quality with nasal septal surgery. (time frame: A postoperative assessment for the aforementioned parameter was made at two months from the day of the surgery.). The study lists 3 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 NCT01592123, which also lists 2 linked publications.
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 7 May 2012.