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.
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)
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Full eligibility criteria for NCT01592123
Ages eligible for Study
18 Years to 65 Years
Genders eligible for Study
Accepts Healthy Volunteers
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.
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;
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.
All locations for NCT01592123
Erzurum, Yakutiye, Turkey, 25240
View full eligibility
Tris trial is registered with FDA with number: NCT01592123. The sponsor of the trial is Ataturk Training and Research Hospital and it is looking for 68 volunteers for the current phase.
Official trial title: Evaluation of Benefits of Nasal Septal Surgery on Subjective Sleep Quality, Daytime and Dream Anxiety
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